- The largest commercial payers in Illinois, Texas, New Mexico, and Oklahoma have adopted Carleon’s Clinical Appropriateness Guidelines-Musculoskeletal Spine Surgery Criteria, which deems one- and two-level lumbar total disc replacement (TDR) medically necessary and expands coverage to over 14 million additional covered lives.
- The largest commercial payer in North Carolina (2.8 million covered lives) has recently adopted Carleon’s Guidelines as well—deeming one- and two-level lumbar total disc replacement (TDR) medically necessary.
- This update comes on top of the recent announcement that Michigan’s largest commercial payer (5.8 million covered lives) has established positive coverage for one- and two-level lumbar TDR.
- Centinel Spine’s prodisc L is the only TDR system in the U.S. approved for two-level use in the lumbar spine.
WEST CHESTER, Pa., Nov. 14, 2023 /PRNewswire/ — Centinel Spine®, LLC, (“the Company”) a leading global medical device company addressing cervical and lumbar spinal disease by providing the most complete and clinically-proven total disc replacement (TDR) technology platform in the world (prodisc®), today announced the adoption of Carleon’s Clinical Appropriateness Guidelines-Musculoskeletal Spine Surgery Criteria by the largest payers in Illinois, Texas, New Mexico, and Oklahoma—representing over 14 million covered lives. Because prodisc L is the only lumbar TDR device with FDA approval for two-level use, these guidelines only apply to the use of prodisc L lumbar TDR in these states.
This major positive coverage update became effective in August 2023 and continues the trend towards significant coverage for two-level lumbar TDR. In September, the largest commercial payer in Michigan added one and two-level lumbar TDR coverage, providing 5.8 million covered lives with access to lumbar TDR. Then, in October, the largest commercial payer in North Carolina adopted Carleon’s Clinical Appropriateness Guidelines-Musculoskeletal Spine Surgery Criteria for lumbar TDR, as well—adding 2.8 million covered lives. With this recent coverage expansion in these four states, it is estimated that over 30% of commercially-covered lives in the U.S now have access to two-level lumbar TDR, while coverage for one-level lumbar TDR has grown from 50% in 2017 to a currently estimated 94% of covered lives.
The adoption of Carleon’s Clinical Appropriateness Guidelines-Musculoskeletal Spine Surgery Criteria specifically excludes devices lacking FDA approval for two-level TDR and explicitly references Centinel Spine’s prodisc L system as being the only TDR system in the U.S. approved for two-level use in the lumbar spine. Additional policy guidelines restrict coverage for the L3-L4 lumbar level to only devices FDA-approved for that use; prodisc L remains the only TDR system in the U.S. approved for use at the L3-L4 level.
According to Osama Ahmed, MD, Neurosurgeon at Brain and Spine Institute of San Antonio, “It’s a huge advancement in patient care that BCBS will now approve two-level lumbar disc replacements. Motion preservation surgery is medically proven and should become more readily available as the paradigm shift away from traditional fusions continues.”
Centinel Spine CEO Steve Murray adds, “The #1 payer in four large states has now provided much needed two-level lumbar TDR access to a significant number of individuals. We look forward to other payers recognizing the clinical benefits of lumbar TDR enabling patients to maintain spinal motion and avoid adjacent segment disease.”
About Centinel Spine, LLC
Centinel Spine®, LLC is a leading global medical device company addressing cervical and lumbar spinal disease by providing the most robust total disc replacement (TDR) technology platform in the world (prodisc®). The Company’s prodisc technology is the most studied and clinically-proven TDR system across the globe, validated by over 540 published papers and 250,000 implantations worldwide.
Centinel Spine continues to advance its pioneering culture and corporate mission to become a catalyst of change in the spine industry and alter the way spine surgery is perceived. The prodisc platform remains the only technology with multiple motion-preserving anatomic solutions allowing the surgeon to Match-the-Disc™ to each patient’s anatomy for both cervical and lumbar total disc replacement.
For more information, please visit the company’s website at www.CentinelSpine.com or contact:
Chief Financial Officer
900 Airport Road, Suite 3B
West Chester, PA 19380
Email: [email protected]
SOURCE Centinel Spine, LLC
- Clinical efficacy top-line results of PARADIGM, a Phase 2b trial in ALS, expected in December 2023
CAMBRIDGE, Mass., Nov. 13, 2023 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a company developing treatments for severe neurodegenerative diseases, today announced it has concluded a successful Type D meeting with the U.S. Food and Drug Administration (FDA) for PrimeC in the treatment of amyotrophic lateral sclerosis (ALS). FDA Type D meetings are focused on a narrow set of issues at key decision points to provide timely feedback critical to move a drug development program forward. The purpose of NeuroSense’s meeting with the FDA was to discuss PrimeC’s chemistry, manufacturing, and controls (CMC) development plans in advance of an expected Phase 3 pivotal study and potential subsequent marketing approval. The FDA agreed with NeuroSense’s proposed CMC development plan. PrimeC has already been granted Orphan Drug Designation by the FDA and the European Medicines Agency (EMA).
“This confirmation from the FDA of our CMC strategy for a future pivotal Phase 3 clinical trial and commercial launch of PrimeC in the treatment of ALS marks a critical milestone in our drug development program. It sets the stage for a smooth transition, particularly as we anticipate clinical efficacy top-line results (secondary endpoints) from our Phase 2b trial very soon,” stated Alon Ben-Noon, CEO of NeuroSense.
NeuroSense is currently conducting PARADIGM (NCT05357950), a multinational, randomized, double-blind, placebo-controlled Phase 2b clinical trial of PrimeC in ALS. Sixty-nine people living with ALS in Canada, Italy, and Israel have been enrolled into PARADIGM, which aims to assess PrimeC’s efficacy, as well as safety and tolerability. Primary and secondary endpoints of the study include assessment of ALS-biomarkers, evaluation of clinical efficacy, and improvement in quality of life. In the double-blind segment trial participants were dosed for 6 months after being randomized 2:1 to receive PrimeC or placebo, respectively. After completion of the double-blind segment, the participants had the option to enroll in a 12-month open label extension (OLE), during which they all receive treatment with PrimeC. 96% of the participants chose to continue into the OLE.
Amyotrophic lateral sclerosis (ALS) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 patients are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of patients with ALS is expected to grow 24% by 2040 in the U.S. and EU.
PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of amyotrophic lateral sclerosis (ALS) that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired RNA regulation to potentially inhibit the progression of ALS. PrimeC was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense’s strategy is to develop combined therapies targeting multiple pathways associated with these diseases.
This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing for release of results from the double-blind segment of the Company’s Phase 2b trial and regarding an expected Phase 3 pivotal study. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include unexpected a delay in the reporting of clinical top-line results from PARADIGM clinical trial, the failure to meet the primary or secondary endpoints of the trial, a delay in patient enrollment for a Phase 2 trial for Alzheimer’s disease or its planned Phase 3 pivotal ALS trial of PrimeC; the potential for PrimeC to safely and effectively target ALS; preclinical and clinical data for PrimeC; the timing of current and future clinical trials, timing for reporting data; the development and commercial potential of any product candidates of the company; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC)., You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 22, 2023. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense Therapeutics Ltd. undertakes no duty to update such information except as required under applicable law.
PARK CITY, Utah, Nov. 3, 2023 /PRNewswire/ — Globally recognized aesthetics device company Powered by MRP announced today that Cole Whitaker will be joining the company to serve as the Chief Commercial Officer (CCO), marking a significant milestone in the company’s journey towards innovation and industry disruption. This strategic addition to the leadership team follows the recent Chief Sales Officer and Chief Technology Officer appointments.
With nearly two decades of experience in the medical laser and aesthetic industry, Whitaker brings a wealth of knowledge to the new role. Prior to joining MRP, he served as the SVP of Technology for Cartessa Aesthetics where he managed all laser and light-based products in the technology portfolio.
“I’m honored to join Powered by MRP,” said Cole Whitaker, CCO at Powered by MRP. “The company’s commitment to pushing the boundaries of innovation and technology is truly inspiring, and I look forward to working alongside a team of dedicated professionals as we continue to shape the aesthetics industry and provide groundbreaking solutions to our clients and partners.”
Whitaker’s previous position as the US Business Development Manager at Lumenis saw him successfully manage the launch of emerging technologies for the US Aesthetics division. Additionally, Whitaker collaborated with industry thought leaders to develop advanced protocols and best practices, further highlighting his commitment to innovation and clinical excellence in the field.
“We are thrilled to welcome Cole as our new Chief Commercial Officer, a pivotal addition to our growing team,” said Scott Carson, Founder and CEO of Powered by MRP. “His extensive experience, coupled with his passion for innovation, perfectly aligns with our mission. We are determined to set new standards in the field of aesthetics, and with Cole on board, we are more confident than ever that we will achieve that goal.”
For more on the Powered by MRP’s leadership team, click here.
About Powered by MRP
MRP is a globally recognized aesthetics device company founded by Scott Carson in 2015. Their technology-driven platform provides a vertically-integrated marketplace that helps Aesthetic Providers lower equipment costs through consultative customer service and GPO-level pricing. MRP is the largest reseller of new and pre-owned energy-based aesthetic and surgical devices in the world. MRP is featured on the viral TikTok “DermDoctor” hosted by distinguished board certified dermatologist Dr. Muneeb Shah, MD.
SOURCE Powered by MRP
New Platform Integrates With All Phacoemulsification Systems,
Saves Time and Space in the OR
CARLSBAD, Calif., Nov. 1, 2023 /PRNewswire/ — Centricity Vision Inc., a global ophthalmic technology company, announced today the commercial launch of its ZEPTOLink IOL Positioning System™ at the American Academy of Ophthalmology (AAO) Annual Meeting, November 3-6 in San Francisco. The new platform seamlessly integrates the clinically proven ZEPTO precision pulse capsulotomy technology with any phacoemulsification (phaco) system to streamline cataract surgery.
ZEPTO is the first and only device that creates an instantaneous capsulotomy with consistent, 360-degree intraocular lens (IOL) overlap for optimal lens positioning and improved outcomes. Now with the phaco integration, ZEPTOLink is the next evolution helping to drive the future of automated refractive cataract surgery.
As part of a controlled market introduction to 12 existing and new users, more than 500 ZEPTOLink procedures have been performed over the past few months, with surgeons reporting greater speed and workflow efficiency with ZEPTOLink.
“The initial response to ZEPTOLink has been extremely positive. Surgeons like having complete control of the procedure via the phaco foot pedal, which is intuitive for them and resulted in a very time-efficient procedure,” said Centricity Vision President and CEO Rob Thornhill.
ZEPTOLink utilizes suction and irrigation provided by the phaco system and enables surgeons to fully control the ZEPTO handpiece, which provides applanation, suction, energy delivery, and capsule release via the phaco foot pedal. Key features include:
- Seamless integration with any phacoemulsification system
- Small, ergonomic console design with user-friendly touchscreen display
- Efficient setup and priming of the ZEPTOLink handpiece by a single person, all within the sterile field
- Clinically proven ZEPTO technology for precise, consistent, and centered capsulotomies with 360-degree IOL overlap
“Having complete control of the ZEPTOLink procedure with the phaco foot pedal is a game-changer for me,” said Tomy Starck, MD, a long-time ZEPTO user. “With ZEPTOLink, I can meet the demands of a high-volume cataract surgery practice without the high cost and workflow interruption of laser.”
“My goal is to deliver optimal outcomes for my patients while maximizing surgical efficiency. ZEPTOLink is fast, accurate, and consistent, allowing me to provide outstanding results for my premium IOL patients. It has fit seamlessly into our practice alongside our femto platform,” said David Stephens, MD.
Following AAO, Centricity Vision will upgrade existing users of the prior ZEPTO system to ZEPTOLink while also onboarding new accounts.
Precision Pulse Capsulotomy
Creating a well-formed, centered capsulotomy is among the most difficult steps of cataract surgery, and it is essential for effective IOL positioning and stability. By applying 12 micro-pulses of energy in just 4 milliseconds, ZEPTOLink enables surgeons to center the capsulotomy with 360-degree IOL overlap on the patient’s visual axis for improved outcomes.1-4 ZEPTO’s precision pulse capsulotomy (PPC) also preserves the endothelial cells of the cornea as well as continuous curvilinear capsulorhexis (CCC or manual capsulorhexis) in cataract surgery.5
About the ZEPTO IOL Positioning System
Designed to enhance the precision and efficiency of cataract surgery, the ZEPTO IOL Positioning System™ is the first and only device that creates an instantaneous capsulotomy for precise, 360-degree IOL overlap and improved outcomes. ZEPTOLink is the next evolution of the technology and is ideal for premium IOLs and complex cases that require enhanced precision. The technology also provides significant cost and time savings with easy workflow integration and increased efficiency per case.
About Centricity Vision Inc.
Based in Carlsbad, California, Centricity Vision is a global ophthalmic technology company and developer of the U.S. and internationally approved ZEPTO IOL Positioning System™. Centricity Vision’s expert team is dedicated to providing advanced surgical solutions to improve long-term visual outcomes and deliver the best vision care to patients. For more information, visit Zeptozone.com, or follow Centricity Vision on LinkedIn, Facebook, and X.
- Thompson V, Holladay J, Sretavan D. Use of P1-P4 Purkinje reflections as a surrogate sign for intraoperative patient fixation. J Cataract Refract Surg. 2021 Dec 1;47(12):e60-e65. doi: 10.1097/j.jcrs.0000000000000805. PMID: 34486578.
- Singh I. For IOL placement, location is key. Ophthalmol Times. 2020;45(11):1,19.
- Ifantides C, Lee J, Rouweyha R, VitalM, Sretavan D. Precision pulse capsulotomy: performance metrics and utility In routine and complex cases. J Cataract Refract Surg. 2020;46(11):1522-1529.
- Gundersen K, Potvin R. Clinical results after precision pulse capsulotomy. Clin Ophthalmol. 2020;14:4533-4540.
- Vital MC, Jong KY, Trinh CE, Starck T, Sretavan D. Endothelial cell loss following cataract surgery using continuous curvilinear capsulorhexis or precision pulse capsulotomy. Clin Ophthalmol. 2023 Jun 16;17:1701-1708. doi: 10.2147/OPTH.S411454. PMID: 37346471; PMCID: PMC10281278.
SOURCE Centricity Vision
LOUISVILLE, Colo., Oct. 26, 2023 /PRNewswire/ — Trio Health (Trio), a leading clinical data solution provider, has announced the appointment of Mia Nease as its Chief Commercial Officer (CCO). In this role, Nease will lead the advancement of Trio’s commercialization strategy and oversee the development of innovative solutions to meet the evolving needs of Trio’s life sciences clients and collaborators.
Mia brings more than 25 years of experience commercializing scientific innovation to Trio. Her career path includes launching a division of Dell Computer in Asia Pacific, initiating a Life Science software strategy for Hewlett Packard, and helping PwC accelerate advisory consulting revenue in the healthcare and life sciences sectors. Most recently, Mia served as the Vice President of Partnerships for Komodo Health.
In addition to her full-time roles, Mia has served on advisory boards of three health-tech startups seeking revenue growth and strategic partnerships. While in her role as CCO at Trio, Mia will continue to serve on the board of Bryleos, an emerging biotechnology company.
Widely recognized as a pioneer in the healthcare technology and life sciences spaces, Mia will play a pivotal role in Trio’s continued expansion that includes the licensing of high-quality clinical data and unique offerings that support all phases of the biopharmaceutical product lifecycle. Mia’s commercial experience and vast international technology and life sciences network will usher in a new phase for Trio.
“There is enormous opportunity for Trio Health that lies ahead,” said Trio CEO, Brent Clough. “We are delighted to have found a high-caliber leader in Mia to accelerate our company to its next stage of growth and to help our customers achieve commercial success.”
“I have known Trio’s CEO Brent Clough for nearly a decade. Trio Health’s growth, combined with the leadership of Yoori Lee, President, reflects the evolution of the healthcare sector. I am honored to join Trio and to continue to grow their vision,” said Nease.
About Trio Health
Trio Health’s mission is to improve quality of care and patient outcomes through coordinating the efforts of all patient care stakeholders. Their first-of-its-kind Multi-Disease Platform (MDX) tracks patients throughout the course of their treatment, giving pharmaceutical/biotechnology companies, specialty pharmacies and physicians access to information and opportunities that simply doesn’t exist anywhere else. Learn more at www.triohealth.com.
SOURCE Trio Health
LOS ANGELES, Oct. 19, 2023 /PRNewswire/ — Expanding Innovations, Inc. (EI), an emerging technology leader in the expandable interbody cage sector of the Spine Industry, has announced the full commercial launch of the X-PAC Expandable Lateral Cage System (X-PAC LLIF).
Some of the first procedures utilizing the cage were performed by Dr. Brandon K. Strenge at the Orthopaedic Institute of Western Kentucky. Dr. Strenge commented, “The X-PAC Expandable Lateral cage design incorporates the fundamental lateral interbody fusion principles of indirect decompression and bridging bone fusion. X-PAC’s maximized posterior expansion aids in foraminal height restoration, facilitating indirect decompression. Additionally, the large open architecture and streamlined post packing instrumentation create an ideal endplate-to-endplate fusion column.”
The launch of X-PAC LLIF represents the first in a series of planned commercial releases aimed at expanding the EI portfolio of NON-SCREW based Expandable Cage Technology. The company is actively developing solutions for ALIF, ATP, and Endoscopic procedures, as well as incorporating integrated fixation and hyperlordotic options within the LLIF portfolio.
“We are pleased with the positive feedback and adoption rate observed during our initial market release, as it is consistent with the success of our flagship product, the X-PAC Expandable Posterior Cage System (X-PAC TLIF). We look forward to entering full commercial launch and growth it represents for our company,” said Robert Jaramillo, CEO of Expanding Innovations.
Expanding Innovations, Inc. (EI) developed a revolutionary, NON-SCREW based expandable technology that surgeons and patients can count on. The X-PAC Expandable Cage design replaces the traditional inner cage lifting screw, with a powerful, continuous expansion mechanism, supported by unidirectional locking teeth, for controlled expansion. The EI portfolio includes the X-PAC Expandable Posterior & Lateral Cage Systems, as well as active development of X-PAC ALIF, ATP & ENDO platforms. For more information about Expanding Innovations please visit www.expandinginnovations.com.
SOURCE Expanding Innovations
– APHEXDA is the first innovation in stem cell mobilization for multiple myeloma to be approved in the U.S. in a decade –
– One dosage of APHEXDA plus filgrastim enabled a majority of patients to achieve the collection goal of ≥ 6 million hematopoietic stem cells among a contemporary population of multiple myeloma patients –
– Management to hold conference call on Tuesday, September 12, 2023 at 8:00 a.m. U.S. EDT –
TEL AVIV, Israel, Sept. 11, 2023 /PRNewswire/ — BioLineRx Ltd. (NASDAQ/TASE: BLRX), a commercial stage biopharmaceutical company focused on certain cancers and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved APHEXDA™ (motixafortide) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma. APHEXDA is administered by injection, for subcutaneous use.
Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9174951-biolinerx-fda-approval-aphexda/
Multiple myeloma is the second most-common hematologic malignancy. Autologous stem cell transplantation (ASCT) is part of the standard of care treatment paradigm for multiple myeloma and delivers prolonged survival for patients with this cancer type.1 The success of ASCT depends on adequate mobilization of stem cells during the treatment process. The American Society for Transplantation and Cellular Therapy (ASTCT) guidelines recommend a collection target of 3-5 x 106 CD34+ cells/kg.2 Additionally, collection of a sufficient number of stem cells to perform two transplantations is recommended.2-5 Historically, depending on induction regimens and mobilization strategies, up to 47% of patients have had challenges collecting target numbers of hematopoietic stem cells for ASCT after one apheresis session.6-7
“Greater numbers of patients with multiple myeloma are candidates for autologous stem cell therapy; however, achieving target collection goals can be difficult in some patients given modern barriers, including the treatment of older patients and use of contemporary induction regimens,” said John DiPersio, MD, PhD, primary investigator for the GENESIS trial and
Professor of Medicine, Pathology and Immunology and Director of the Center for Gene and Cellular Immunotherapy at Washington University School of Medicine in St. Louis. “Innovation in this area of medicine has been needed, and today’s approval of APHEXDA addresses the demand for new therapies that can meet today’s challenges by delivering more reliability in stem cell mobilization, versus filgrastim alone, with fewer days of apheresis sessions and fewer doses of filgrastim for people living with this cancer.”
The FDA approval of APHEXDA is based on results from the 2-part, Phase 3 GENESIS trial, a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of APHEXDA (motixafortide) plus filgrastim, compared to placebo plus filgrastim, for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients. Part 1 was a single center, lead-in, open-label study involving 12 patients treated with motixafortide plus filgrastim designed to ascertain the dose. Part 2 involved 122 patients who were randomized 2:1 in a double-blind, placebo-controlled, multicenter study.8
The assessment of CD34+ cells was performed by central and local laboratories. Central laboratory assessments were used for the efficacy results. Local laboratory results were used for clinical treatment decisions. APHEXDA plus filgrastim enabled 67.5% of patients to achieve the stem cell collection goal of ≥ 6 × 106 CD34+ cells/kg within two apheresis sessions, versus 9.5% for the placebo plus filgrastim regimen, as measured by central laboratory.9 Additionally, 92.5% of patients reached the stem cell collection goal in up to two apheresis sessions in the APHEXDA arm and 21.4% in the placebo arm, as measured by local laboratories.9 Local laboratory data were used for a sensitivity analysis. The data are descriptive and were not statistically powered nor prespecified. The information should be cautiously interpreted.
In GENESIS, the safety was evaluated in 92 patients with multiple myeloma who received APHEXDA 1.25 mg/kg subcutaneously plus filgrastim, and 42 patients who received placebo plus filgrastim. Serious adverse reactions occurred in 5.4% of patients receiving APHEXDA plus filgrastim. These reactions included vomiting, injection site reaction, hypersensitivity reaction, injection site cellulitis, hypokalemia and hypoxia. The most common adverse reactions occurring in GENESIS (incidence >20%) were injection site reactions (pain, erythema and pruritus), pruritus, flushing, and back pain.9
“Given the strong efficacy data shown in the GENESIS trial, which included patients who are representative of the current multiple myeloma patient population, we believe APHEXDA will play a critical role in addressing unmet needs and introduce a new treatment paradigm for this challenging cancer,” said Philip Serlin, Chief Executive Officer of BioLineRx Ltd. “The company is working relentlessly to make this important innovation in stem cell mobilization available to appropriate patients, their physicians and transplant teams.”
“FDA approval of APHEXDA, the company’s first approved therapeutic, is a tremendously exciting and important moment in our history and validates our drug development programs,” said Ella Sorani, PhD, Chief Development Officer of BioLineRx Ltd. “We would like to thank all of the patients and families who have contributed to the research and development of APHEXDA.”
Increased age, as well as exposure to lenalidomide-containing induction regimens, including 3-4 drug combination regimens, have been associated with impaired stem cell mobilization.2-3 The GENESIS study included patients considered representative of the typical multiple myeloma population undergoing ASCT, with a median age of 63 years and with ~70% of patients in both arms of the trial receiving lenalidomide-containing induction therapy.8 In this contemporary population, patients in the APHEXDA plus filgrastim arm were able to mobilize more than four times the amount of stem cells with a single dose over a 24-hour period compared with placebo plus filgrastim.8
BioLineRx expects to make APHEXDA available later this month. For further information about APHEXDA, please see the Important Safety Information below and the full Prescribing Information, and visit www.APHEXDA.com.
APHEXDA Investor Conference Call
The Company will host an investor conference call on September 12, 2023 at 8:00 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer.
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until September 14, 2023; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that affects some white blood cells called plasma cells, which are found in the bone marrow. When damaged, these plasma cells rapidly spread and replace normal cells in the bone marrow. According to the American Cancer Society, in 2023, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and nearly 13,000 people will die from the disease in the U.S.10 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems, or infections.
About Autologous Stem Cell Transplantation
Autologous stem cell transplantation (ASCT) is part of the standard treatment paradigm for a number of blood cancers, including multiple myeloma. In the U.S., as many as 8,000 ASCTs are performed each year in patients with multiple myeloma.11 The current ASCT standard of care includes 4-6 cycles of induction therapy (an initial drug-combination regimen to position the patient for as deep a treatment response as possible). To begin the stem cell mobilization process, a patient will receive a daily dose of filgrastim (G-CSF) for four days. Daily doses of filgrastim will continue until the target collection goal is met with the addition of up to four daily doses of plerixafor as needed.12 For patients unable to mobilize sufficient numbers of cells for harvesting during this primary mobilization phase, rescue therapy may be carried out followed by an additional number of apheresis sessions as necessary.2
About the GENESIS Trial
GENESIS (NCT 03246529) is a 2-part, Phase-3, randomized, double-blind, placebo-controlled, multicenter study evaluating the safety and efficacy of APHEXDA (motixafortide) plus filgrastim (G-CSF), compared to placebo plus filgrastim, for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients. Part 1 was a single center, lead-in, open-label study involving 12 patients treated with motixafortide plus filgrastim designed to ascertain the dose. Part 2 involved 122 patients who were randomized 2:1 in a double-blind, placebo-controlled, multicenter study.8
The primary objective of the study was to evaluate if one dose of motixafortide plus filgrastim is superior to placebo plus filgrastim in the ability to mobilize ≥ 6 million CD34+ cells in up to two apheresis sessions. A key secondary objective of the study was to evaluate if one dose of motixafortide plus filgrastim is superior to placebo plus filgrastim in the ability to mobilize ≥ 6 million CD34+ cells in one apheresis session.8
The study met the primary endpoint with a high degree of statistical significance (p<0.0001). The assessment of CD34+ cells was performed by central and local laboratories. Central laboratory assessments were used for the efficacy results. Local laboratory results were used for clinical treatment decisions. APHEXDA plus filgrastim enabled 67.5% of patients to achieve the cell collection goal of ≥ 6 × 106 CD34+ cells/kg in up to two apheresis sessions with a single administration, versus 9.5% for the placebo plus filgrastim regimen, as measured by central laboratory.9 Additionally, 92.5% of patients reached the stem cell collection goal in up to two apheresis sessions in the APHEXDA arm and 21.4% in the placebo arm, as measured by local laboratories.13 Local laboratory data were used for a sensitivity analysis. The data are descriptive and were not statistically powered nor prespecified. The information should be cautiously interpreted.
The safety of APHEXDA was evaluated in 92 patients with multiple myeloma who received APHEXDA 1.25 mg/kg subcutaneously plus filgrastim and 42 patients who received placebo plus filgrastim for mobilization of hematopoietic stem cells for collection and apheresis. Serious adverse reactions occurred in 5.4% of patients receiving APHEXDA plus filgrastim. Serious adverse reactions included vomiting, injection site reaction, hypersensitivity reaction, injection site cellulitis, hypokalemia and hypoxia. The most common adverse reactions occurring in GENESIS (incidence >20%) were injection site reactions (pain, erythema, and pruritus), pruritus, flushing and back pain.9
Please see important safety information below.
APHEXDA (motixafortide) is a CXCR4 antagonist with long receptor occupancy (greater than 72 hours) that, in combination with filgrastim (G-CSF), enables mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous stem cell transplantation in patients with multiple myeloma.9
INDICATION AND IMPORTANT SAFETY INFORMATION
APHEXDA is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
IMPORTANT SAFETY INFORMATION
APHEXDA is contraindicated in patients with a history of serious hypersensitivity reactions to motixafortide.
WARNINGS AND PRECAUTIONS
- Anaphylactic Shock and Hypersensitivity Reactions: Anaphylactic shock and hypersensitivity reactions have occurred. Premedicate all patients with a triple drug premedication regimen that includes an H1-antihistamine, an H2 blocker, and a leukotriene inhibitor approximately 30-60 minutes prior to each dose of APHEXDA. Administer APHEXDA in a setting where personnel and therapies are immediately available for treatment of anaphylaxis and other systemic reactions. Monitor patients for 1 hour following APHEXDA administration and manage reactions promptly. Patients receiving negative chronotropic drugs (e.g., beta-blockers) may be more at risk for hypotension in the event of a hypersensitivity reaction and these drugs, when appropriate, should be replaced with non-chronotropic drugs.
- Injection Site Reactions: Injection site reactions (73%) including pain (53%), erythema (27%), and pruritus (24%) have occurred. Severe reactions occurred in 9% of patients. Premedicate with an analgesic premedication (e.g., acetaminophen) prior to each APHEXDA dose. Use analgesic medication and local treatments post-dose, as needed.
- Tumor Cell Mobilization in Patients with Leukemia: For the purpose of hematopoietic stem cell (HSC) mobilization, APHEXDA may cause mobilization of leukemic cells and subsequent contamination of the apheresis product. Therefore, APHEXDA is not intended for HSC mobilization and harvest in patients with leukemia.
- Leukocytosis: Administering APHEXDA in conjunction with filgrastim increases circulating leukocytes as well as HSC populations. Monitor white blood cell counts during APHEXDA use.
- Potential for Tumor Cell Mobilization: When APHEXDA is used in combination with filgrastim for HSC mobilization, tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. The effect of potential reinfusion of tumor cells has not been well-studied.
- Embryo-fetal Toxicity: Based on its mechanism of action, APHEXDA can cause fetal harm. Advise pregnant women of the potential risk to the fetus. Verify pregnancy status in females of reproductive potential prior to initiating treatment with APHEXDA and advise use of effective contraception during treatment and for 8 days after the final dose.
The most common adverse reactions (incidence >20%) in patients treated with APHEXDA were injection site reactions [73%, including pain (53%), erythema (27%), pruritus (24%)]; pruritus (38%); flushing (33%); back pain (21%).
USE IN SPECIFIC POPULATIONS
Pregnancy: Please see the important information in Warnings and Precautions under Embryo-fetal Toxicity.
Lactation: There are no data on the presence of motixafortide in human milk, the effects on the breastfed child, or the effects on milk production. Advise females that breastfeeding is not recommended during treatment with APHEXDA and for 8 days after the final dose.
Pediatric Use: The safety and effectiveness of APHEXDA have not been established in pediatric patients.
Please see the accompanying full Prescribing Information.
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a commercial stage biopharmaceutical company pursuing life-changing therapies for certain cancers and rare diseases. The company’s first approved product is APHEXDA™ (motixafortide) with an indication in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma. BioLineRx is advancing a pipeline of investigational medicines for patients with sickle cell disease, pancreatic cancer, and other solid tumors. Headquartered in Israel, and with operations in the U.S., the company is driving innovative therapeutics with end-to-end expertise in development and commercialization, ensuring life-changing discoveries move beyond the bench to the bedside.
Forward Looking Statement
Various statements in this release concerning BioLineRx’s future expectations constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” and “would,” and describe opinions about future events. These include statements regarding management’s expectations, beliefs and intentions regarding, among other things, the potential benefits of APHEXDA, the timing of the launch of APHEXDA and the plans and objectives of management for future operations and expectations and commercial potential of motixafortide. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx’s actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of BioLineRx’s preclinical studies, clinical trials and other therapeutic candidate development efforts; BioLineRx’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; whether the clinical trial results for APHEXDA will be predictive of real-world results; BioLineRx’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of BioLineRx’s therapeutic candidates, including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA receives adequate reimbursement from third-party payors; BioLineRx’s ability to establish and maintain corporate collaborations; BioLineRx’s ability to integrate new therapeutic candidates and new personnel; the interpretation of the properties and characteristics of BioLineRx’s therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx’s business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx’s expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing, including any unexpected costs or delays in the commercial launch of APHEXDA; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx’s industry; statements as to the impact of the political and security situation in Israel on BioLineRx’s business; and the impact of the COVID-19 pandemic and the Russian invasion of Ukraine, which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the “Risk Factors” section of BioLineRx’s most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 22, 2023. In addition, any forward-looking statements represent BioLineRx’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.
- Kumar SK, et al. Blood. 2008;111(5):2516-2520.
- Giralt S, et al. Biol Blood Marrow Transplant. 2014;20(3):295-308.
- Giralt S, et al. Leukemia. 2009;23(10):1904-1912.
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- Edmisson J, et al. Poster presented at: 64th American Society of Hematology Annual Meeting and Exposition; December 10-13, 2022; New Orleans, LA.
- DiPersio JF, et al. Blood. 2009; 113(23):5720-6.
- Crees, ZD, et al. Future Oncology. 2019;15(30):3555-3563.
- APHEXDA. Prescribing Information. BioLineRx Ltd; 2023.
- American Cancer Society. Key Statistics About Multiple Myeloma. Atlanta, Ga: American Cancer Society; 2023.
- Auletta JJ, et al. Current use and outcome of hematopoietic stem cell transplantation: CIBMTR US summary slides. 2021.
- Multiple Myeloma Research Foundation. Multiple Myeloma Treatment Overview. Norwalk, Conn.: Multiple Myeloma Research Foundation; 2019.
- BioLineRx. Data on File #1005. June 29, 2023.
SOURCE BioLineRx Ltd.
The funding will support Intuition Robotics’ growth as demand surges for loneliness interventions, and fuel its continued development of ElliQ’s relationship and conversational capabilities, powered by generative AI and deep utilization of Large Language Models (LLMs)
RAMAT GAN, Israel, Aug. 29, 2023 /PRNewswire/ — Intuition Robotics announced today that it has secured a first closing of a new funding round amounting to $25 million, $20M in venture capital and $5M in venture debt, and led by Woven Capital, the growth fund of Toyota, with participation from Toyota Ventures, OurCrowd, Western Technology Investment, and additional investors. The funding will help the company meet surging demand for its AI care companion ElliQ across government aging agencies and healthcare organizations. It will also allow the company to deepen integrations into the healthcare system and help aging populations better connect with others, and better access much-needed products and services while reducing costs.
Loneliness is an epidemic that can cause serious harm to health, with the U.S. Surgeon General recently advising that experiencing loneliness can increase the risk of death equivalent to smoking 15 cigarettes a day. The U.S. healthcare system is increasingly seeking solutions, with legislation recently introduced to create a national policy to promote social connection and address soaring rates of loneliness.
Intuition Robotics has pioneered ElliQ, an AI companion designed to enhance the lives of older adults by combating loneliness and promoting healthy and independent living. In an era dominated by groundbreaking technologies, ElliQ has consistently demonstrated its ability to engage users over time and positively impact the lives of older individuals with its proactive suggestions and conversational capabilities. ElliQ provides companionship and support for older adults through daily health check-ins, cognitive and physical activities, connection to family and friends, and more using a simple and intuitive interface.
“Intuition Robotics is advancing the future of mobility for aging populations by offering human connection and access to goods and services that they couldn’t obtain otherwise,” said Nicole LeBlanc, a partner at Woven Capital who is also joining the company’s board of directors. “The company is leading the way by providing a field-proven solution that delivers strong results, improving social infrastructure and serving overlooked markets in unique, thoughtful, and powerful ways. These are precisely the values behind the future of mobility that Toyota is bringing to life, making Intuition Robotics a natural fit for Woven Capital.”
The funding round comes on the heels of a successful commercial launch with government agencies across the United States. Intuition Robotics has initiated programs to distribute ElliQ at no cost to end users with the New York State Office for the Aging, the Area Agency on Aging of Broward County, the Olympic Area Agency on Aging, and California’s Agency on Aging in Area 4. In addition, the company signed its first agreement with a Managed Care Organization focusing on Medicare beneficiaries. In the state of New York, the product has shown unprecedented engagement levels with users averaging over 30 interactions with ElliQ per day. It has been proven to reduce loneliness for 95% of users.
The latest advancements in Generative AI and the prevalence of transformers and Large Language Models (LLMs) have allowed Intuition Robotics to integrate rich and continuous conversational experiences into ElliQ. By leveraging these advancements, ElliQ has deepened its conversational abilities, allowing for an even deeper relationship to evolve between ElliQ and the user. The company has developed technology that chooses the areas where to integrate multiple LLMs seamlessly into the experiences such as sparking the creativity of the users by painting with ElliQ through the use of DALLE2, augmenting scripted conversations, and achieving deeper contextual understanding. This is done with guardrails and algorithmic control on the integrity of the experience.
“We’ve seen the direct impact that loneliness has had on our aging community, but we’ve also seen the positive results our AI and technology have on the older adult population. Beyond the groundbreaking results in reducing loneliness – ElliQ is also seeing an impact on health, wellness, and behavior change,” said Dor Skuler, CEO and Co-founder of Intuition Robotics. “The latest advancements in AI have advanced ElliQ’s conversational capabilities to become even more contextual, personalized, and goal driven. We’re proud to be at the forefront of harnessing this technology for the benefit of our users. We are excited to utilize this new funding to deploy more ElliQ devices out into the world, further increase its accessibility, expand partnerships, and gain a deeper understanding of the role ElliQ can play in the healthcare ecosystem. We are grateful for the support of Woven Capital and our additional investors as we continue our mission to empower older adults to live happier, healthier, and more independent lives at home,”
“Since we first invested in Intuition Robotics in 2017, we’ve been inspired by the team’s mission to empower older adults using AI. It’s exciting to see the progress they’ve made over the years – from ElliQ’s initial development and testing, to the commercial deployment and now a growing number of partnerships,” said Jim Adler, founder and general partner of Toyota Ventures. “We share the company’s vision of using technology to amplify the human experience and look forward to seeing how ElliQ will continue to enrich the lives of older adults.”
About Intuition Robotics
Intuition Robotics is on a mission to empower older adults to live happier, healthier, and more independent lives at home. The company’s award-winning product, ElliQ®, is a proactive care companion for older adults. ElliQ helps keep users healthy, engaged, and informed, while alleviating the effects of loneliness and social isolation. Intuition Robotics has won several awards for its work with ElliQ including Fast Company’s Most Innovative Companies and the CES Best of Innovation award. The company was founded in 2016 and investors include: Woven Capital, Toyota Ventures, Samsung NEXT, iRobot, OurCrowd, Terra Ventures and Venture Capital firms from California, Israel, Japan, and Asia. To learn more, please visit intuitionrobotics.com.
SOURCE Intuition Robotics
KFAR SABA, Israel, July 26, 2023 /PRNewswire/ — CartiHeal Ltd., developer of implants for the treatment of cartilage and osteochondral defects in arthritic and non-arthritic knee-joints, today announced its first commercial implantation of Agili-C in the US by Dr. Ken Zaslav, a specialist in Orthopedic Surgery and Sports Medicine at Northwell Health in New York City, NY.
The Agili-C implant features a bi-phasic design that supports both bone remodeling and cartilage regeneration. Agili-C received FDA breakthrough designation status in 2020 and demonstrated clinical superiority to the surgical standard of care (SSOC)—microfracture and debridement—in one of the largest cartilage clinical trials on record with the broadest inclusion criteria, which was meant to mimic real-life patients. This resulted in the Agili-C implant receiving FDA approval with an indication for the treatment of an International Cartilage Repair Society (ICRS) grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7cm2, without severe osteoarthritis (Kellgren-Lawrence grade 0-3).
Dr. Zaslav commented, “Agili-C is a technology I and others in the surgical community have been watching and waiting on for over 10 years. It is a novel implant supported by 4-years of data and counting from the multinational, randomized and controlled IDE clinical trial. Agili-C offers a cost efficient, off-the-shelf implant to fill an unmet need in my clinical practice.”
“We are thrilled to share the Agili-C technology with the surgical community with a goal for it to reach every surgical facility in the US and beyond,” said Nir Altschuler, CartiHeal’s Founder and CEO. “This is a milestone achievement for everyone at CartiHeal and we would like to congratulate Dr. Zaslav on successfully performing our first commercial case in the US.”
Agili-C is available nationwide.
CartiHeal is an Israel and New Jersey based, privately held medical device company focused on the design, development, and commercialization of proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.
The Agili-C™ scaffold is indicated for the treatment of an International Cartilage Repair Society grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7cm2, without severe osteoarthritis (Kellgren-Lawrence grade 0-3).
For more information
TORONTO, July 14, 2023 /CNW/ – Northwest Healthcare Properties Real Estate Investment Trust (TSX: NWH.UN) (the “REIT”) announced today that the Trustees of the REIT have declared a distribution of $0.06667 per unit for the month of July 2023, representing $0.80 per unit on an annualized basis. The distribution will be payable on August 15, 2023, to unitholders of record as at July 31, 2023.
About Northwest Healthcare Properties Real Estate Investment Trust
Northwest Healthcare Properties Real Estate Investment Trust (TSX: NWH.UN) (Northwest) is an unincorporated, open-ended real estate investment trust established under the laws of the Province of Ontario. As at March 31, 2023, the REIT provides investors with access to a portfolio of high-quality international healthcare real estate infrastructure comprised of interests in a diversified portfolio of 233 income-producing properties and 18.6 million square feet of gross leasable area located throughout major markets in Canada, the United States, Brazil, Europe, Australia and New Zealand. The REIT’s portfolio of medical office buildings, clinics, and hospitals is characterized by long-term indexed leases and stable occupancies. With a fully integrated and aligned senior management team, the REIT leverages over 300 professionals in ten offices in eight countries to serve as a long-term real estate partner to leading healthcare operators.
This press release contains forward-looking statements which reflect the REIT’s current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual results could differ materially from those projected herein. The REIT disclaims any obligation to update these forward-looking statements.
SOURCE NorthWest Healthcare Properties Real Estate Investment Trust
For further information: please contact Paul Dalla Lana, CEO at (416) 366-8300 x 1001.