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.”

Stryker’s T2 ICF Nail System Offers Surgeons New Option for Patients Suffering from Serious Foot Conditions

Media Release:

MAHWAH, N.J., September 28, 2020—Stryker’s Trauma & Extremities division today announced the launch of its T2® ICF Intramedullary nailing system, offering a solution for patients suffering from serious foot conditions such as Charcot foot—a condition associated with diabetes resulting in poor bone quality, possible nerve damage and potential foot ulcers.1

The T2 ICF system is a stable product that provides a surgical option designed to prevent nail back out and promote fixation and accuracy. It is estimated that a leg is amputated every 30 seconds globally, and 85% of these amputations are the result of diabetic foot ulcers.2

“We are always looking for ways to improve fixation strategies in Charcot patients, as they tend to have poor bone quality and often end up needing limb-salvage procedures,” said Vinod Panchbhavi*, MD, FACS, FAOA, FABOS, FAAOS, Professor and Chief of Ankle & Foot Surgery, UTMB Health. “The T2 ICF nails are lightweight and sturdy, are easy to use.”

“This medial and lateral column nail provides rigid fixation with the ability to apply up to 10 millimeters of compression through the nail3,” said William Simon*, DPM, Bayview Physicians Group, and designer of the T2 ICF nail. “The stable nail is designed to be compatible with cross screws to help prevent nail back-out4 and the large nail diameters are intended to help prevent nail breakage3.”

The T2 ICF Intramedullary nailing system can also be used to treat other conditions such as fracture fixation, osteotomies, non- and mal-unions, and fusions.