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

Fashion for pointy shoes unleashed plague of bunions in medieval Britain

Press release:

The British have suffered for their fashion for centuries according to a new study suggesting that a vogue for shoes with a pointed tip led to a sharp increase in hallux valgus of the big toe – often called bunions – in the late medieval period.

Researchers investigating remains in Cambridge, UK, found that those buried in the town centre, particularly in plots for wealthier citizens and clergy, were much more likely to have had bunions – suggesting rich urbanites paid a higher price for their footwear in more ways than one.

A University of Cambridge team also discovered that older medieval people with hallux valgus were significantly more likely to have sustained a broken bone from a probable fall compared to those of a similar age with normal feet.

Hallux valgus is a minor deformity in which the largest toe becomes angled outward and a bony protrusion forms at its base, on the inside of the foot.

While various factors can predispose someone to bunions, from genetics to muscle imbalance, by far the most common contemporary cause is constrictive boots and shoes. The condition is often associated with wearing high heels.

Archaeologists analysed 177 skeletons from cemeteries in and around the city of Cambridge and found that only 6% of individuals buried between 11th and 13th centuries had evidence of the affliction. However, 27% of those dating from the 14th and 15th centuries had been hobbled by longstanding hallux valgus.

Researchers point out that shoe style changed significantly during the 14th century: shifting from a functional rounded toe box to a lengthy and more elegant pointed tip.

In a paper published today in the International Journal of Paleopathology, the team from Cambridge University’s After the Plague project argues that these “poulaine” shoes drove the rise of bunions in medieval Britain.

“The 14th century brought an abundance of new styles of dress and footwear in a wide range of fabrics and colours. Among these fashion trends were pointed long-toed shoes called poulaines,” said study co-author Dr Piers Mitchell from Cambridge’s Department of Archaeology.

“The remains of shoes excavated in places like London and Cambridge suggest that by the late 14th century almost every type of shoe was at least slightly pointed – a style common among both adults and children alike.”

“We investigated the changes that occurred between the high and late medieval periods, and realized that the increase in hallux valgus over time must have been due to the introduction of these new footwear styles,” said Mitchell.

First author Dr Jenna Dittmar, who conducted the work while at Cambridge, said: “We think of bunions as being a modern problem but this work shows it was actually one of the more common conditions to have affected medieval adults.”

The remains came from four separate sites around Cambridge: a charitable hospital (now part of St John’s College); the grounds of a former Augustinian friary, where clergy and wealthy benefactors were buried; a local parish graveyard on what was the edge of town; and a rural burial site by a village 6km south of Cambridge.

Researchers conducted “paleopathological assessments”, including inspecting foot bones for the bump by the big toe that is the hallmark of hallux valgus.

They found a sliding scale of bunion prevalence linked to the wealth of those interred on each site. Only 3% of the rural cemetery showed signs, 10% of the parish graveyard (which mainly held the working poor), creeping up to 23% of those on the hospital site.

Yet almost half those buried in the friary – some 43% – including five of the eleven individuals identified as clergy by their belt buckles, carried the mark of the bunion.

“Rules for the attire of Augustinian friars included footwear that was ‘black and fastened by a thong at the ankle’, commensurate with a lifestyle of worship and poverty,” said Mitchell.

“However, in the 13th and 14th centuries it was increasingly common for those in clerical orders in Britain to wear stylish clothes – a cause for concern among high-ranking church officials.”

In 1215, the church forbade clergy from wearing pointed-toed shoes. This may have done little to curb the trend, as numerous further decrees on indiscretions in clerical dress had to be passed, most notably in 1281 and 1342.

“The adoption of fashionable garments by the clergy was so common it spurred criticism in contemporary literature, as seen in Chaucer’s depiction of the monk in the Canterbury Tales,” said Mitchell.

Across late medieval society the pointiness of shoes became so extreme that in 1463 King Edward IV passed a law limiting toe-point length to less than two inches within London.

The majority of remains with signs of hallux valgus across all sites and eras within the study were men (20 of the 31 total bunion sufferers). The research also suggests that health costs of foot fashion were not limited to bunions.

Dr Jenna Dittmar found that skeletal remains with hallux valgus were also more likely to show signs of fractures that usually result from a fall e.g. those to upper limbs indicating an individual tumbled forward onto outstretched arms.

This association was only found to be significant among those who died over 45 year old, suggesting youthful fashion choices came back to haunt the middle-aged even in medieval times.

“Modern clinical research on patients with hallux valgus has shown that the deformity makes it harder to balance, and increases the risk of falls in older people,” said Dittmar. “This would explain the higher number of healed broken bones we found in medieval skeletons with this condition.”

Adaptive Phage Therapeutics Announces FDA Clearance of IND Application for PhageBank™ in Treatment of Diabetic Foot Osteomyelitis

Adaptive Phage Therapeutics (APT), a clinical-stage biotechnology company dedicated to advancing therapies that address the global rise of multi-drug resistant infections, announced today that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for PhageBank™ phage therapy for the treatment of Diabetic Foot Osteomyelitis (DFO).

“Advancing PhageBank therapy targeting diabetic foot osteomyelitis is a critical step in providing viable treatment options to diabetic patients facing significant morbidities, including potential amputation”Tweet this

“Advancing PhageBank therapy targeting diabetic foot osteomyelitis is a critical step in providing viable treatment options to diabetic patients facing significant morbidities, including potential amputation,” said Greg Merril, CEO and co-founder of Adaptive Phage Therapeutics. “Today’s announcement marks the third successful IND application by APT in the last year, further validating the potential of our novel PhageBank™ platform to more effectively treat a range of drug-resistant bacterial infections and enabling APT to rapidly progress towards multiple clinical inflection points.”

DFO is the result of soft tissue infections in diabetic patients that spread into bone. Based on research by The Center for Biosimilars, someone is diagnosed with diabetes every 17 seconds, and 230 people with diabetes will suffer an amputation every day in the United States. Globally, it is estimated that a leg is amputated every 30 seconds, with 85% of these amputations resulting from a diabetic foot ulcer(1). With more than 1.5 million patients worldwide being diagnosed with diabetes each year, amputations as a result of diabetes comprise a significant portion of non-trauma related amputations. The American Diabetes Association estimates that 20% of patients with diabetic foot infections, and more than 60% of those with severe infections, have underlying osteomyelitis, placing patients at significantly higher risk of amputation(2).

APT’s PhageBank™ is a precision-matched phage therapy that specifically targets bacterial pathogen(s) identified as the cause of patient infection. PhageBank™ comprises a library of purified phages covering a broad spectrum of bacterial species. APT has also developed a proprietary PhageBank Susceptibility Test™ (PST) to rapidly identify the specific phage(s) required to provide precision therapy of bacterial infections.

The Defense Health Agency, a branch of the Department of Defense (DoD), is an integrated Combat Support Agency that enables the military’s medical services to provide a ready medical force in any situation. In 2019 the DoD awarded APT a $14 million contract for advanced development of its PhageBank™ platform. The award is funded by the Defense Health Agency and the Naval Medical Research Center.

APT is advancing clinical trials for all three initial PhageBank™ target indications: in Diabetic Foot Osteomyelitis (DFO), Prosthetic Joint Infections (PJI), and Urinary Tract Infections (UTI). APT’s Phase I/II PhageBank™ DFO trial is planned as a randomized, open-label, parallel-group, controlled study to evaluate the safety and efficacy of PhageBank™ therapy in conjunction with standard of care versus standard of care. APT plans to initiate the DFO clinical trial in 2021, with a first interim data analysis expected in 2022.

1)https://www.ajmc.com/view/increasing-awareness-this-national-diabetes-month-can-save-limbs-and-lives
2)https://www.ncbi.nlm.nih.gov/books/NBK554227/

Adaptive Phage Therapeutics, Inc.

Adaptive Phage Therapeutics (APT) is a clinical-stage company advancing therapies addressing multi-drug resistant infections. Prior antimicrobial therapeutic approaches have been “fixed,” while pathogens continue to evolve resistance to each of those therapeutics, causing those drug products to become rapidly less effective in commercial use as antimicrobial resistance (AMR) increases over time. APT’s PhageBank™ approach leverages an ever-expanding library of bacteriophage (phage) that collectively provide evergreen broad spectrum and polymicrobial coverage. PhageBank™ phages are matched through a proprietary phage susceptibility assay that APT has teamed with Mayo Clinic Laboratories to commercialize on a global scale. APT’s technology was originally developed by the biodefense program of U.S. Department of Defense. APT acquired the world-wide exclusive commercial rights in 2017. Under FDA emergency Investigational New Drug allowance, APT has provided investigational PhageBank™ therapy to treat more than 40 critically ill patients in which standard-of-care antibiotics had failed.

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.

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.

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.

ACFAS Releases New Position Statement on Board Certification in the Specialty of Foot and Ankle Surgery

Press Release:

10/20/2020

CHICAGO-October 20, 2020   – The American College of Foot and Ankle Surgeons (ACFAS), a national surgical association of over 7,800 foot and ankle surgeons released a new position statement on board certification within the specialty of foot and ankle surgery.

The podiatric profession in the United States is subdivided into two specialties, podiatric medicine and podiatric (foot and ankle) surgery. ACFAS supports the recognition of one board per specialty, as determined by the Joint Committee on the Recognition of Specialty Boards (JCRSB) of the Council on Podiatric Medical Education (CPME).

ACFAS recognizes the American Board of Foot and Ankle Surgery (ABFAS) as the certifying board in the specialty of foot and ankle surgery. The complete statement, Board Certification in the Specialty of Foot and Ankle Surgery, can be found at acfas.org/PositionStatements.

ACFAS President Scott Nelson, DPM, FACFAS explains why the position statement is important for the profession. “ACFAS believes the statement can be a useful resource for hospitals and insurance companies to help define the role of the certifying boards for the specialty of Doctors of Podiatric Medicine.” Dr. Nelson adds, “Board certification serves as a critical element of public trust that stringent requirements have been met. Certification by the American Board of Foot and Ankle Surgery is often considered the benchmark for the foot and ankle surgeon.”