Tag: press release

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Sensoria Health and DARCO Join Forces to Create Smart Diabetic Footwear

Press release:

Partnership will deliver remote patient monitoring connected podiatry solutions to patients and providers

Dec. 22, 2021 / PRZen / REDMOND, Wash. — Sensoria® Health and DARCO International, Inc. announce their partnership to jointly develop smart diabetic footwear that is powered by mobile and cloud patient monitoring technology.

This new partnership will combine industry leading Sensoria’s remote patient monitoring software, and Sensoria® Core hardware technologies together with DARCO’s world class podiatry products.

“The combination of Sensoria’s remote patient monitoring wearable technology, behavioral feedback enabled mobile apps and artificial intelligence Microsoft Azure cloud software solutions along with DARCO’s manufacturing, medical footwear design, and diabetic wound offloading expertise will help reduce risk of amputations and improve people’s lives. We are excited about this partnership and look forward to bringing the next generation of diabetic footwear to market,” says Davide Vigano CEO of Sensoria Health.

One of the most dangerous and expensive complications of diabetes is represented by diabetic foot wounds, which will occur in up to one third of people with diabetes. The total worldwide cost of diabetic limb complications is estimated to be $48B. In the US, direct costs associated with these complications exceeds the cost of each of the five most expensive cancers.

According to the World Health Organization, over 422 million people suffer from diabetes. In many countries, including the USA, diabetes is now an emergency of epidemic proportions, and diabetic foot complications are one of the most painful effects: in the world every 20 seconds, a lower limb is lost due to diabetes.

This partnership will be a joint development effort that will rapidly incorporate Sensoria’s technology with selected DARCO products and will create a new category of solutions for podiatrists. These new products will not only provide valuable feedback to patients but will also supply clinician’s compliance and usage patterns for healing diabetic foot ulcers and reduce the risk of recurrence.

“It is now obvious that connected footwear will play a major role in the future of diabetic care. In the US, CMS is embracing remote patient monitoring and is launching new reimbursement for remote therapeutic monitoring. Our partnership with Sensoria® Health will place both of our companies in a leadership position for smart podiatry footwear products around the globe,” says Darrel Darby CEO of DARCO International.

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Hewlett Packard announce Arize Custom Orthoses

Press Release:
New Arize Custom Orthoses to Help Podiatrists Relieve Foot Pain for Millions
Arize Orthotic Solution enables podiatrists and orthotists to prescribe custom orthoses tailored to their patients’ specific needs in less than five minutes
July 29, 2021

News Highlights:
Disrupting an industry and improving patient wellness: 77% of Americans experience foot pain.
The Arize Orthotic Solution enables access to accurate, high-quality and custom orthoses helping create lasting and dependable products for podiatrists and their patients.
Simple, easy-to-use solution leveraging HP 3D printing and cloud-based software provides clinics with efficiencies at every step and helps podiatrists improve patient outcomes

PALO ALTO, Calif., July 29, 2021 — HP Inc. today announced the Arize Orthotic Solution, a new end-to-end digital orthotic solution for podiatrists and orthotists. Currently, 77% of Americans experience foot pain and the fast, easy-to-use digital solution upends traditional manufacturing methods and delivers quality custom orthoses and consistent results, every time[ii]. Using a blend of advanced 3D printing and cloud-based software, Arize enhances the development and delivery of custom-fit prescriptive orthoses and streamlines business operations to take foot health into the next generation. Podiatrists and orthotists can capture 3D renderings of a patient’s foot, fine-tune and prescribe personalized orthoses for their patients – all in less than five minutes[iii].

Arize disrupts the status quo with a new kind of efficiency and optimizes customization capabilities not possible through traditional processes[iv]. For example, Arize can automatically detect anatomical landmarks found in the 3D printed foot scan, so that providers can approve or modify as needed. Providers can also adjust details to enhance form, fit, and function, with thin, light, and low-profile orthoses enabled by 3D printing, improving patient satisfaction. Starting with five familiar styles – functional, sports, stability, everyday comfort, and dress/low profile – providers can leverage the design flexibility enabled by 3D printing to tailor the orthoses based on patient need and activity level.

“The Arize Orthotic Solution has increased my clinic’s productivity and has allowed me to be more efficient due to the ease of use and streamlined workflow,” said Dr. Gavin P. Ripp of Premier Podiatry & Orthopedics. “I’ve been using Arize in my practice for the past six months and my patients are excited about the innovative, lightweight, and low-profile 3D printed custom orthoses. Plus, with Arize, I can easily place reorders and I receive consistent fitting orthoses every time.”


Enhancing Process, Driving Efficiency, Empowering Clinicians
The Arize cloud-based architecture streamlines clinic operations and efficiencies, providing access for the clinic’s full staff to all current patients and their prescription status. For example, an office administrator can start a patient intake while scheduling an appointment. Clinicians and technicians can then conduct the 3D scan and make customizations, leaving final prescription submission for podiatrists and orthotists to review. With greater flexibility to tap into the patient profile from virtually anywhere, Arize brings collaboration back into the practice, meaning more fluid operations and less time navigating roadblocks.

“With its Arize Orthotic Solution, HP has married a highly accurate 3D scanning solution, with an intuitive and elegant clinic interface and custom 3D printed designs that are likely to change the orthotics industry for the foreseeable future,” said Dr. Jack Reingold of Coast Podiatry Group of Solana Beach Inc.


3D Printing Helping Podiatrists Improve Patient Outcomes
This new solution is a testament to the digital revolution – taking advantage of HP’s industry-leading Multi Jet Fusion 3D printing technology to help podiatrists deliver individually customized products. For podiatrists and specialty clinics challenged by highly variable, manual processes, Arize leverages proprietary HP innovations in digital software and data intelligence to provide a solution with highly accurate, repeatable, and consistent digital workflows.

“I’m confident the new Arize solution and HP’s future technology roadmap will transform the podiatry market and most importantly improve patient outcomes,” said Dr. Bruce Williams, President, Breakthrough Sports Performance, and consultant to HP. “Arize enables innovative orthotic design and unmatched efficiency for clinics looking to provide the highest quality custom foot orthoses.”

3D printing is a key enabler to help clinics in the shift toward a more circular, sustainable, and inclusive economy. Orthoses produced with HP’s Multi Jet Fusion technology can be made to optimize materials use while delivering fine detail combined with strength. 3D printing also brings production closer to the point of consumption, which simplifies supply chains and drives reductions in carbon emissions and waste[v].

“At HP, we are committed to accelerating entirely new market opportunities and driving the sustainable manufacturing of personalized products across industries,” said Philipp Jung, GM of Arize and Global Head of Orthotic Solutions, HP Inc. “With our end-to-end digital expertise and 3D printing capabilities, we are bringing a new way of working to the prescriptive orthotics business, one that streamlines the way providers serve patients, conduct business, and operate. From innovative design capabilities to cost savings and improved time management, Arize enables podiatrists to provide a higher level of service and better patient outcomes.”

HP has worked closely with an independent Advisory Council consisting of leading industry experts to develop the Arize solution and to design a long-term roadmap to ensure ongoing advancements to help clinicians achieve better patient outcomes. Members of the Advisory Council include Paul Langer, Vice President of Operations for Langer Biomechanics; Sally Crawford, Director of Technology & Data Management at Resilience Code, LLC; Dr. Jay Segel of Segel Podiatry; Dr. Jason Surratt of Northwest Extremity Specialists; and Dalia Zwick PT, Ph.D. a rehab clinical supervisor.

Learn More About the Breakthrough Arize Orthotic Solution
The new Arize Orthotic Solution will be on display in Booth 811/910 at the American Podiatric Medical Association (APMA) Annual Scientific Meeting (The National) in Denver, July 29 to August 1, 2021. The must-attend meeting for podiatrists offers attendees a diverse educational program touching on all aspects of foot and ankle surgery and medicine.

The Arize team will be joined by Dr. Jay Segel on Saturday, July 31 at 9:45 am at the Innovation Café as they present ‘Introducing Arize: an innovative 3D printing orthotic solution.’ Led by Melanie Shelton, Arize Product Manager, see how fast and easy the solution is, and how it can help podiatrists improve business results by improving workflow and providing repeatability with consistent results.

About the Arize Orthotic Solution
Developed in collaboration with podiatrists and leading industry experts, Arize is a new digital solution that helps podiatrists create custom foot orthoses tailored to the patient, quickly, easily, accurately, and reliably. The Arize Orthotic Solution leverages HP 3D Printing technology and aims to further HP’s mission to create technology that makes life better for everyone, everywhere. More information on the Arize Orthotic Solution can be found at ArizeClinical.com.

Footnotes:
American Podiatric Medical Association (APMA), 2014
[ii] Based on internal HP testing, March 2021, that generated multiple orders with the same prescription and matched the hash values for each file from each order for a visual comparison.
[iii] Based on internal HP testing, March 2021. Actual results depend on many factors including patient-doctor interactions and specific patient conditions.
[iv] Compared to traditional manual processes, 3D printing is a digital technology that creates objects by selective addition of material (additive manufacturing). This allows each 3D-printed part to be unique in the same way that each page printed by an inkjet or laser printer can have unique content. 100% customized custom content page-to-page and part-to-part is a capability digital technologies bring to 2D and 3D printing. To learn more, see hp.com/go/MJFWhitepaper.
[v] hp.com/go/sustainableimpactreport2019

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FDA Approves Accu-Joint Hemi Implant, a Hemi-arthroplasty Metatarsal Head or Phalangeal Base Implant for the Metatarsophalangeal (MTP) Joint

Accufix Surgical TM today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to distribute its patented Accu-Joint system, a revolutionary new approach intended to enable full restoration of MTP function and motion, with no resecting or weakening of hard bone. The unique, non-weight bearing implant, allows surgical podiatrists to choose joint preservation over joint fusion for their patients. The Accu-Joint is intended to functionally and accurately restore arthritic toe joints, while allowing original anatomic bone structure to remain intact. It is also intended to be implanted with Hallux Valgus correction, providing that procedure is being performed.

Breakthrough Benefits

The Accu-Joint system consists of two patented technologies that separate it from competitors.

A unique two-stage MTP joint reamer removes worn cartilage, smooths bone spurs and countersinks the hard subchondral bone end of the toe joint, resulting in complete resurfacing for precise implant seating and bone ingrowth, preserving bone anatomy and bone length. At the same time, second-stage blades produce 360-degree clearance around the implant articular edge, allowing the implant to articulate in a smooth manner.

Secondly, the implants include cancellous threaded, solid stems – not cannulated – intended to provide rigid fixation and help prevent influx of infection into the medullary canal, along with grooves and scalloped edges under the articular head of the implant to allow bone ingrowth for reliable anti-rotation. The threaded “barrel” of the stem, just beneath the articular surface, transfers all stress forces off the stem, and away from the softer medullary canal, into the hard subchondral bone where it is rigidly fixated. The implants are sized smaller than the diameter of the bone end, which together with 4-points of internal rigid fixation, is intended to ensure that the bone – not the implant – bears the full weight of the body, while delivering the strength and implant stability necessary for full foot function.

True Anatomical Joint Preservation

“As a practicing podiatrist for 36 years, I have been dissatisfied with joint replacement implant options for my patients.” recalls Dr. Glenn C. Vitale, the inventor of the Accu-Joint. “I have surgically removed many failed implants and have chosen not to use any of the joint implants that are currently on the market today.”

“We finally have the opportunity to choose true anatomical joint preservation over joint fusion.” Fusions represent approximately 80% of current MTP procedures, yet are prone to reduced range of motion and can inhibit quality of life and limit the choice of shoe gear.

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Carbon22 receives FDA clearance of the Creed™ Cannulated Screw System

Carbon22’s ortholucent manufacturing technology offers several key benefits, including radiotransparency that greatly improve visualization of bony structures.

ENGLEWOOD CLIFFS, NJ, UNITED STATES, December 20, 2020 /EINPresswire.com/ — Carbon22™, a GLW, Inc. company, announced today that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market the Creed™ Cannulated Screw System, a portfolio of unique, see-through “ortholucent” bone screws used for foot and ankle surgery. The Creed System was developed in collaboration with the Carbon22 consortium, a select group of orthopedic and podiatric surgeons.

The Creed system is a streamlined, multi-component platform featuring a distinctive, proprietary hybrid screw composite, consisting of a titanium core with an overmold of Solvay Zeniva® PEEK resin. Carbon22’s ortholucent manufacturing technology offers several key benefits, including radiotransparency. While using medical imaging (both during and after surgery), the radiotranslucent properties of these novel headed and headless compression screws greatly improve visualization of bony structures. The Creed screws are offered in a comprehensive selection of diameters (2.5, 4.3, 5.6 and 7.4mm) that are available in a broad range of lengths.

Carbon22 has created a bridge between materials science and device design, positively transforming the performance, manufacturing process and logistics of implant systems. These devices drastically improve cost-effectiveness, while maintaining, or improving patient outcomes.

“As surgeons, we continue to develop effective, skill-based surgical approaches to improve patient outcomes; however, device innovation has not kept up – until now,” noted Dr. Carroll P. Jones, director of the Foot and Ankle Fellowship Program at OrthoCarolina. “The Creed System is a pioneering device that provides a significant clinical advantage over traditional metal implants by radically improving intraoperative and postoperative visualization of bones and joint spaces.”

With a widened cannulation, Creed screws accept larger diameter k-wires and feature an enhanced self-drilling, self-tapping cutting screw tip that is unique to Carbon22. Combined, these features help limit k-wire bending and reduce the amount of bone chips displaced by the screw, allowing the surgeon to implant with less effort.

Dr. A. Holly Johnson, orthopedic surgeon at New York City’s Hospital for Special Surgery, stated, “The Creed System is a long-awaited advancement in cannulated screw design. Carbon22’s ortholucent technology has the potential to greatly improve our ability, as surgeons, to assess post-operative healing.” Designed for maximum efficiency, the Creed screws and instruments are packaged sterile and surgery ready. Disposable instrument kits are available for all screw sizes, eliminating reprocessing costs. “Unlike surgical systems that are used repeatedly in hundreds of surgical procedures, Carbon22’s Creed System ensures that every patient is treated with a sterile, single-use implant and new instruments functioning at their peak condition,” commented Axel Cremer, Chief Technology Officer for Carbon22.

Dr. Lowell Weil Jr., CEO of the Weil Foot & Ankle Institute, emphasized that “Carbon22 has taken the next step by targeting its manufacturing processes and production costs, allowing it to provide the Creed System at the same price or lower than other manufacturers’ conventional titanium screws.” This pricing flexibility will allow the company to aggressively penetrate and disrupt the U.S. foot & ankle implant market, estimated to be greater than $1 billion.

Carbon22 and GLW have an exclusive agreement with Solvay S.A. for the future development of medical-grade polymers.

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About Carbon22, a GLW Inc. company

Carbon22 is a privately held company, focused on the design and development of cost-effective, high-margin implant and instrument solutions for various musculoskeletal foot & ankle applications. Carbon22 and its products are commercialized in the US market through exclusive distribution and education agreements with Novastep, Inc.

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OnTheSpot Arches for Instant Arch Support

Press Release:

[Croydon, 5 November 2020]. OnTheSpot are pleased to announce that their instant arches are now available to purchase. These silicone gel arch pads are designed to be used in the types of footwear that it is not normally possible to get arch supports into, such as ballet flats, football boots and flip flops.

OnTheSpot Arches for Instant Arch Support

OnTheSpot can either be purchased in pairs by consumers or in bulk by health professionals to purchase to use or on-sell to their patients. The pads have a self adhesive backing so can easily be placed in the footwear and moved around until a comfortable spot is found. People often ask how they can get arch support in these types of shoes and we have the solution for that problem.

Please see the companies website for more information and where to purchase these.