TendoMend Ltd. is a private Israeli medical device start-up company developing and commercializing an innovative Dynamic Tendon Grip (DTG™) surgical device to replace the traditional, time-consuming nonunified suturing techniques of tendon laceration and rupture repairs. Hand tendon lacerations, which count for about 2/3 of tendon surgery repairs, are particularly difficult to treat with over 25% of complications and patients achieving an unsatisfactory clinical outcome, and more than 7% of repairs, requiring repeat surgery. There is a clear need for a better solution for tendon repair facilitating improved healing, fewer complications and revised surgery, shorter and standardized procedures and improved short and long-term outcomes.
Dr. Brian Polsky, Orthopaedic Surgeon and Sports Medicine Specialist in Catonsville, Columbia, and Eldersburg, serves on the Medical Advisory Board of TendoMend and spoke with MIDC recently about TendoMend’s cadaver trials and work in Maryland.
What is TendoMend’s DTG Device?
The DTG™ surgical device is comprised of an innovative knots array implant made out of the strongest braided suture and deployment applicator; both are single-use devices. The loop/knot-configured implant establishes a grip that is based on an external embrace of the entire tendon enabling a controlled, stable, and accurate alignment between the two torn tendon stumps. This prevents damage to the tendon texture and allows for a stronger, less traumatic anastomosis while maintaining the original tendon profile and permits smooth gliding through the pulleys (tunnels) with minimal trauma to the surrounding tissues.
TendoMend’s Connection to Maryland
Following successful animal safety studies in Turkey model with follow-up and histopathology evaluation, the Company has conducted a safety and feasibility biomechanical studies in the human cadaver model. In these studies, The DTG™ implant demonstrated superiority over the traditional suturing repair in achieving a low-profile flexor tendon repair that did not impair finger range of motion even without pulley venting, higher load to failure force, and the clinically non-significant gap formation between the two stumps. Moreover, repair failure with the implant occurred at the suture level and not at the knot level, making the repair success less reliant on the surgeons’ skill and more reliant on stronger suture materials. The cadaver biomechanical study was accepted and published last April as an article in the BMC Musculoskeletal Disorders, a leading orthopedic journal under the title “ Dynamic Tendon Grip (DTG™) novel knot array compared to traditional sutures for zone two flexor tendon injury – a biomechanical feasibility study.
TendoMend also conducted last October a hand cadaver trial at the Cadaver Lab in Howard County. The trial was performed by Dr. Khurram Pervaiz and Dr, Brian Janz, two senior hand surgeons of the Center of Advanced Orthopedic (CAM – https://www.cfaortho.com/). The procedure and the first-time use of the DTGTM device by the above surgeons and the deployment of the DTGTM implant were performed without any major difficulties. The results were impressive and the loading of the tendon while moving the finger did not create any gap, enabled smooth gliding, and held a substantial force. Both Dr. Khurram and Dr. Janz were excited about the DTG device and its performance and looked forward to participating in TendoMend’s clinical trial in the US.
Clinical Need for TendoMend
The company is scheduled to initiate in Q3 this year following the DTGTM device finetuning and device freeze an FIH clinical trial in Israel to prove the device’s safety and efficacy on a small scale. A multicentral clinical trial in excellence centers in the US is scheduled for Q2 next year as part of a multicentral clinical trial in excellence centers in the US.
The Company will enter the US market in Q2 of 2024 following the receipt of market clearance by the FDA. The initial market release will be a soft launch in which the device will be sold to a limited number of hospitals, which will serve as centers of excellence. The choice of hospitals to be included in the initial market release will be based on using leading orthopedic surgeons who will serve to extensively promote the DTG™ device within the surgical community. These Key Opinion Leaders (KOL’s) will promote the device in peer-reviewed journals, leading conferences (ASSH, AAHS, etc.), training seminars and by participating in online promotional campaigns. Three of the initial sites for commercial utilization are expected to be the Centers of Advanced Orthopedic in Maryland; Washington University Hospital’s Orthopedics department for use by the Company’s advisor Prof. Martin Boyer, head of the Hand and Microsurgery service, and Stanford University Medical Center’s Division of Plastic and Reconstructive Surgery for use by the Company’s advisor Prof. James Chang, Chief of the division.
The Company will prepare for its launch with a detailed upstream marketing plan (hospital-dedicated economic value models, marketing collateral, social media, etc.) and a sales support plan (training materials, seminars, small hospital-centered post-marketing studies, etc.).
Following initial commercial sales in the US the Company expects at the beginning of 2025 to expand into Europe. In the EU the Company will focus first on 1-2 major countries and will use leading local distributors in the orthopedic market.
The Company’s goal as part of this soft launch is to generate maximum exposure for the device within the orthopedic community and industry as well as to generate initial revenues – particularly in the US market. These two elements are expected to position the Company such that it will attract a large strategic partner, which will lead to large-scale marketing of the device worldwide. Such an agreement is expected to be secured during the second half of 2024, leading to substantial market expansion during 2025 and onwards.
What stage is the company in now?
The company has accomplished the development and manufacturing of an advanced DTGTM device prototype, and successful pre-clinical, and cadaver biomechanical studies with significantly better results and outcomes in comparison to the current suturing practice. Four different patent families have already been submitted describing the innovative DTGTM technology and device and the first one has already been granted by the patent offices in the US and Europe. Accomplishing finetuning of the device is scheduled during Q3 of this year with the announcement of the device freeze and proceeding with the FIH clinical trial and the FDA regulatory clearance track. The company had initiated discussions with multinational orthopedic companies such as DePuy Synthesis (J&J orthopedic company), Zimmer Biomet, Arthrex, and Medartis, which have shown great interest in the DTGTM technology and device and expressed their interest to enter into cooperation once entering into the clinical trial phase.
What is the company looking for in Maryland?
Here are the two main objectives:
a. A leading center for performing the multi-central clinical trial in cooperation with The Centers of Advanced Orthopedic and later for a soft launch of the device in the US market.
b. Participation of the local medical angel investors and clubs in the company’s current bridge funds raising round prior to entering into a strategic partnership with one of the multinational orthopedic companies.
More information about TendoMend can be found on their website.