- 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
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
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
Published: Oct. 17, 2023 at 4:08 a.m. ET
By Anthony O. Goriainoff
Abingdon Health said its pretax loss narrowed as revenue rose on the increased commercial momentum over the year, and that it continued working with current and new customers across different contract service projects.
The U.K. diagnostics company said Tuesday that for the year ended June 30 pretax loss was 3.55 million…
By Anthony O. Goriainoff
Abingdon Health said its pretax loss narrowed as revenue rose on the increased commercial momentum over the year, and that it continued working with current and new customers across different contract service projects.
The U.K. diagnostics company said Tuesday that for the year ended June 30 pretax loss was 3.55 million pounds ($4.3 million) compared with a loss of GBP21.6 million the year before.
Revenue rose to GBP4 million from GBP2.8 million.
The company said cash burn significantly fell in the second half when compared to the first, and that this was due to the combined effect of revenue growth and the reduced costs stemming from the operational structuring undertaken in the first half. It added that cash burn continued to reduce on a monthly basis.
Abingdon said that cash as at June 30 was GBP3.2 million, up from GBP2.4 million in the year prior-period, and in line with the board’s expectations.
“We are confident that our contract services customer base and our current growing pipeline means we are well positioned to grow our business and deliver shareholder value going forward,” it said.
Shares at 0756 GMT were down 2 pence, or 15%, at 11 pence.
Write to Anthony O. Goriainoff at email@example.com
IMed launches new UKRP resource to inform businesses after surge in demand for UKRP services
OXFORD, England, July 3, 2023 /PRNewswire/ — IMed Consultancy, a rising regulatory and compliance consultancy provider has launched a new UKRP-focused website to shed light on the role of the UK Responsible Person. With extensive experience supporting UK and international medical device and in vitro diagnostic medical device manufacturers, the company identified a need to help educate the manufacturing industry, and specifically businesses wanting to launch or keep a medical device on the UK market, on the role of the UKRP. Visit the website here.
The requirements for businesses wanting to enter the market in Great Britain are as follows as of January 2021:
- Registering with the MHRA
- Appointing a single UK Responsible Person (UKRP) for all of their devices. This person will act on their behalf to carry out specified tasks, such as registration
- Compliance with relevant product marking and conformity assessment requirements for medical devices
A UK Responsible Person, or UKRP, is a requirement for ensuring a medical device can be placed and maintained on the UK market. The UKRP acts on behalf of businesses based outside the UK to carry out all tasks needed to successfully place their device on the UK market and liaise with entities such as the MHRA. UKRPs are also responsible for ensuring the declaration on conformity and all technical documentation have been drawn up, keeping available a copy of all relevant documentation and immediately informing manufacturers about complaints and reports from healthcare professionals, patients and users.
After seeing a surge in demand for UKRP services, IMed decided to set up a dedicated website, reviewed and developed by the Consultancy’s team of experienced UK regulatory professionals, to resolve UKRP related concerns and questions. IMed’s UKRP website will not only guarantee a fast-track access to IMed’s UKRP services, but will also give companies access to free resources and answers to common concerns via the FAQ section.
“We’re fully aware of the difficulties foreign companies are facing when deciding to place a medical device or IVD on the UK market, especially with changing requirements and the MHRA continuously updating guidance,” explains Matthew Burton, Strategic Development Director at IMed Consultancy. “Choosing the right UKRP, can definitely make all the difference when it comes to placing and maintaining a new medical device on the market so medical device manufacturers should pick a trusted partner, and preferably one that shares their vision, to support them in their business journey. That’s why we all agreed a new web site would be the perfect way to give companies access to useful resources and information, as well as offering our direct support and UKRP services,” concludes Burton.
For more information visit www.ukrp.org
About IMed Consultancy
Founded in 2012, IMed Consultancy offers a wide range of regulatory and compliance services to the medical technology industry supporting medical device and in vitro medical device manufacturers through all stages of the product lifecycle from: concept and design consultancy through to providing resources and strategic counsel regarding clinical studies and post market surveillance activities. IMed Consultancy’s team of highly skilled and experienced medical regulatory professionals offer an outstanding yet accessible global regulatory service. With over 50 years of combined hands-on problem-solving expertise, our remit is truly global, ensuring that client devices are successfully launched and maintained in total compliance in the UK, EU and internationally.
SOURCE IMed Consultancy
PEMBROKE PINES, Fla., May 24, 2023 /PRNewswire/ — EOSolutions Corp., a pioneering medical technology company focused on delivering high-quality catheter solutions, is proud to introduce the Dr. Banner, Balloon Guide Catheter (BGC). Developed in collaboration with InNeuroCo, a leading design, consulting, and contract manufacturing group, Dr. Banner sets new benchmarks in catheter technology, providing physicians with unparalleled capabilities, which include the largest inner diameter (ID) of 0.091, improved proximal stability, distal trackability, and a super compliant polyurethane balloon.
Dr. Banner’s features ensure physicians have access to cutting-edge tools for navigating complex anatomies and achieving optimal patient outcomes. This state-of-the-art device is a result of extensive research and development efforts by EOSolutions Corp., aimed at delivering superior catheter solutions that address the evolving needs of healthcare professionals.
Key Features of Dr. Banner:
Largest Inner Diameter (ID)1: Dr. Banner boasts an impressive inner diameter of 0.091 in, offering a wide lumen for seamless device delivery. This generous ID allows for efficient navigation of complex anatomies and enables the use of larger therapeutic devices.
Proximal Stability and Distal Trackability1: The Coaxial Design with an eight zone stainless-steel inner member and reinforced two zone polyethylene outer member of Dr. Banner ensures excellent proximal stability, providing physicians with precise control during catheter manipulations. Additionally, its exceptional distal trackability enables smooth navigation through tortuous vessels, minimizing trauma and enhancing procedural success. The coaxial design also provides fast inflation and deflation times.
Super Compliant Polyurethane Balloon1: Dr. Banner’s super compliant balloon’s ability to conform to the vessel wall provides immediate confirmation of vessel occlusion minimizing procedural risks.
“Dr. Banner marks a significant milestone in the field of neurovascular interventions,” said Anthony Parise, General Manager and Head of Sales & Marketing at EOSolutions Corp. “With its unparalleled inner diameter, proximal stability, distal trackability, and super compliant polyurethane balloon, Dr. Banner empowers physicians to overcome the challenges of complex anatomies, providing precise and effective treatment options for their patients. We are excited to respond to the needs of our physicians by introducing this groundbreaking catheter that will improve upon their ability to perform the most challenging neurovascular procedures.”
EOSolutions Corp. remains dedicated to pushing the boundaries of medical innovation and delivering cutting-edge solutions to healthcare professionals worldwide. Dr. Banner exemplifies the company’s commitment to creating advanced catheter technologies that enable physicians to provide superior patient care and drive positive clinical outcomes.
For more information about Dr. Banner and EOSolutions Corp., please visit www.eosolutionscorp.com.
About EOSolutions Corp.: EOSolutions Corp. is a leading medical technology company committed to developing advanced solutions for neurovascular procedures. With a focus on innovation, EOSolutions Corp. combines extensive research, engineering excellence, and clinical expertise to deliver state-of-the-art catheter technologies. By addressing the evolving needs of healthcare professionals, EOSolutions Corp. strives to enhance patient care and improve outcomes.
Contact: Anthony Parise, EOSolutions Corp., [email protected]
1Supporting Data on file at EOSolutions Corp.
SOURCE EOSolutions Corp.
For the first time in a commercial setting, physicians are able to see the extent of disease and provide more personalized and precise treatments for prostate cancer patients using AI.
CULVER CITY, Calif., April 25, 2023 /PRNewswire/ — Avenda Health, an AI healthcare company creating the future of personalized prostate cancer care, today announced its FDA cleared prostate cancer management platform, Unfold AI™, is being used for the first time in a commercial setting with patients at a renowned U.S. research hospital. Several physicians at the hospital, including Wayne Brisbane, MD, are using the technology.
Avenda Health’s Unfold AI platform is being used to support physicians and patients with treatment selection, planning, guidance, and follow-up. It combines patient-specific data from prostate imaging, biopsies, and pathology into deep-learning algorithms to create a unique and tailored cancer estimation map. Its 3D, AI-generated map visualizes the location of the cancer for physicians to use in treatment decision making and interventional planning.
“This is a major step forward for the prostate cancer community and we are beyond thrilled to see a decade of hard work and research pay off,” said Dr. Leonard Marks, co-founder and Chief Medical Officer of Avenda Health. “Our mission at Avenda Health is to create a better quality of life for prostate cancer patients and to give urologists a clearer view of the cancer so we can better treat our patients. Unfold AI will improve clinical care and decision making.”
Validated in multiple clinical studies, urologists have improved their sensitivity of identifying the extent of the tumor to over 98% with Unfold AI. In clinical trials, guidance from the platform caused physicians to change their treatment recommendations in 28% of the cases, many times towards a more localized treatment. Based on the results provided by Unfold AI, multiple treatment options can be chosen including active surveillance, whole gland treatments, like radical prostatectomy and radiation therapy, or a soft tissue laser ablation using a device from Avenda Health — FocalPoint.
“With a wide breadth of ablative options available, Unfold AI represents the first technology to improve tumor localization and patient selection,” said Wayne Brisbane, M.D., assistant professor of urology. “I am hopeful that Unfold AI will be to intraprostatic staging what prostate-specific membrane antigen PET-CT has been for extraprostatic staging. Additionally, there are potential applications for surgery, radiation therapy, and patient decision-making.”
In December of 2022, Unfold AI received 510(k) clearance by the U.S. FDA. For more information, visit avendahealth.com.
About Avenda Health
Avenda Health is creating a more personalized future of prostate cancer care. Using deep learning, Avenda Health software maps a patient’s cancer in 3D, giving physicians precise information and the confidence to make care decisions. Dedicated to bringing this cutting-edge technology to all practices and physicians treating prostate cancer patients, Avenda Health aims to improve outcomes, preserve quality of life, and create a new standard of cancer care.
SOURCE Avenda Health
MONTREAL, Nov. 22, 2022 /PRNewswire/ – MY01 Inc. is pleased to announce that Jay Merkel has joined the organization in the role of Chief Commercial Officer (CCO).
Jay was recently the Global Franchise Leader at Integra Life Sciences and had responsibility for the $300+ million dollar global wound reconstruction business. She joined Integra as part of the acquisition of ACell Inc where she was the General Manager, Global Surgical and Cardiac. Prior to this role at ACell, Jay had responsibility as the Sr. Director of Marketing focused on downstream marketing activities, communications, market access, and reimbursement. Previously, Jay held marketing leadership positions at Becton Dickinson, Carefusion, Olympus, and B. Braun. Jay has a B.S. in Mechanical Engineering from Case Western Reserve University and an MBA from Lehigh University College of Business.
Jay commented, “I am thrilled to join the MY01 team and help change the landscape of how compartment syndrome is diagnosed and treated. MY01’s product offers pressure trend information to the clinician through the use of advanced digital technology, and care teams can have that information readily available to them through our mobile app. I’m excited by the immense potential of this platform technology to change the standard of care and improve patient outcomes. It is also an opportunity to join a group of dedicated people who have brought this product to initial commercialization, and I am excited to work with them in continuing to grow brand and product awareness in the field.”
“Jay has demonstrated throughout her career that she can drive growth strategies that maximize momentum and build strong brands”, said Charles Allan, MY01 CEO and President. “I am confident that Jay will quickly make a strong impact on our efforts to make MY01 the gold standard in aiding in the diagnosis of compartment syndrome.”
About MY01, Inc. MY01 Inc. is on a mission to empower healthcare professionals with the ability to preempt severe medical conditions thereby improving patient outcomes. MY01 believes that adding actionable quantitative data at the bedside can augment clinical assessments to provide more effective care collaboration that result in a more effective patient care. Headquartered in Montreal, Quebec since 2015, MY01 Inc. leverages its expertise in microsensor technology to provide innovative diagnostic solutions.
SOURCE MY01, Inc.