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tendomend

An Innovative Technology and Device for Tendon Rupture Repair -
The Dynamic Tendon Grip (DTGTM) Implant and Delivery System

At a Glance

TendoMend is developing and commercializing the DTGTM surgical device, aiming to replace the traditional suturing procedure of tendon rupture repairs, which are associated with high prevalence of complications and revision surgery. The DTG™ device is composed of an applicator and an implant unit enabling a safer and more effective repair of ruptured tendons. The device was conceptualized, designed and built by an experienced team of medical device entrepreneurs and senior engineers in close collaboration with Israel’s leading orthopedic surgeons.

 

The Need

Suturing has been the standard of care in tendon repair for decades. There is currently no unified suturing technique for tendon repair with surgeons using a variety of different suturing methods.  One of the more common techniques is the “Modified Kessler” which is limited by its ability to allow an applied force of only 40 Newtons during tendon suturing. This force is considered as too weak in many of the cases in order to keep the two stumps firmly together post-op for at least 6-8 weeks which is critical for the regeneration of the connective tissue and to ensure proper healing. Hand tendon lacerations are notoriously difficult to treat with over 25% of patients achieving an unsatisfactory clinical outcome as assessed by the clinician, and over 7% of repairs, require repeated surgery. Most of the complications are due to either adhesion of the tendon with surrounding tissues once passive physiotherapy is implemented post-op or re-rupture in the case of active physiotherapy is adopted. These complications originate from the limitations of today’s surgical suturing approach. There is a clear need for a better solution for tendon repair facilitating improved healing, fewer complications, shorter and standardized procedures and improved long-term outcomes.


Our Solution

Dynamic Tendon Grip (DTG)

The Company’s Dynamic Tendon Grip (DTG™) device is comprised of an implant and a dedicated applicator,  both of which are single-use. The unique knot array configured implant is based on several knots, known as the Whoopie Sling. The Whoopie Sling is an adjustable loop that locks under stress and functions as a ratchet, establishing a grip that externally embraces the entire tendon. The mechanism of the DTG™ implant enables an applied controlled preloaded force, as well as stable and accurate alignment between the two torn tendon stumps. It prevents damage to the tendon tissue integrity, allowing for a stronger, less traumatic repair, while maintaining a low profile to permit smooth gliding through the pulleys.

The DTG animation 

 

Milestone Accomplished


• DTG™ technology development and completion of advanced DTG™ prototypes for hand tendon repair
• Manufactured product for pre-clinical and cadaver trials and for demonstration purposes with leading surgeons in Israel and the US.
• Successful completion of efficacy hand cadaver biomechanical trials
• Successful completion of preclinical safety and efficacy trials with follow-up and histological evaluation in animal tendon (turkey) model
• Two patent applications together with an Expert search, confirming strength of broadened IP.
• Helsinki approval for FIH clinical trial in process
• Scientific Advisory Board, Key Opinion Leaders and Surgeons recruited.

 

Intellectual Property

Tendomend maintains a robust and growing intellectual property portfolio. National applications on the initial technology titled, "Advanced Tendon Grasping Devices and Devices for Their Application” were submitted in the US (Aug 2019); and in Europe (EPO, Sep 2019). In addition, a Provisional patent application titled “Tissue Repair System” was submitted in Sep 2020. The company sees strategic value in protecting its intellectual assets and has assigned Dr. Guy Kotlizky, a senior patent attorney to manage its IP portfolio and strategy. 


The Market and Business Strategy

The global market potential for the Company’s DTG™ device for hand tendons is estimated to be $500M, based on a conservative pricing of $600 per DTG™ device kit. The market potential for other upper and lower extremity tendon rupture repairs (Achilles, Quadriceps and Bicep) increases the market potential by a further $200M.
The company plans at to expand its DTG™ technology by continually investing in the R&D and engineering required to deploy the necessary design modifications needed for end-to-end anastomosis of orthopedic soft tissues in Arthroscopic surgery. These include indications such as Anterior Cruciate Ligament (ACL) ruptures and Rotator Cuff Repair.

 

Management Team:

PELED SHAHAR, CEO
Over 20 years’ experience in the medical device frame, with over ten years of experience leading medical device start-ups with proven business achievements.
Holds a bachelor's degree in microbiology Engineering, Technion, Haifa and an MBA.

ALMON EHUD, CO-FOUNDER & BD DIRECTOR
More than 20 years diversified experience as serial entrepreneur and CEO of Israeli public and private start-up companies in the Med-Tech and Bio-Tech spaces.
Building value to start-up ventures from early idea stage, raising tens of millions $ of seed funding, entering into alliances with strategic partners and leading the journey to commercial success. Co-founder & CEO of F.D. Cardio Ltd. (strategic partnership with Boston Scientific Inc).; Co-founder & CEO of CardioSafe Ltd. overseeing a technology transfer deal with Xtent Inc. CEO of Organitech Inc., an Ag-biotech public start-ups company (NASDAQ)

PROF. VALAVANIS IOANNIS, CO-FOUNDER &CMO
A leading Greek orthopedic surgeon at the private Athens Medical Group of hospitals since 2001 and former Director of Orthopaedic Department at KAT Hospital in Athens, Greece. Dr. Valavanis did his fellowship practice in the U.S. and also completed a Ph.D. in Biomedical engineering.
DR. SHEZIFI YUVAL, CTO
Medical Device specialist with over 20 years’ track record "Hands on" experience in implant devices, instrumental in innovative design, developing, testing and manufacturing and clinical trials of many innovative medical devices. Ph.D. studies at the Technion Institute of Technology. Served as CTO in several medical device start-ups such as Endostream, Keystone Heart Ltd., Expandis Ltd., and Insyscope Ltd.

Advisory Board:

DR. YONA YANIV
Head of the Hand Surgical Department in Sheba Medical Center. Former chair of the Israeli's hand surgery association.


DR. MORDEHAI VIGLER
Head of the hand surgery unit at Rabin Medical Center, Senior Orthopedic Surgeon, specializes in Hand Surgery.

 

DR. YAFA LEVANON 

Director of Handheld Rehabilitation Unit at Tel Hashomer Rehabilitation Hospital, PhD in upper limb rehabilitation. Lecturer in Tel Aviv University. About 35 years’ experience in the Sheba Medical Center in the field of hand rehabilitation including Nerve tendon injuries, fractures and musculoskeletal disease and more.

 

 

Contact information  

Ehud (Udi) Almon, Co-founder & BD Director
TendoMend Ltd.
P.O. Box 1252, Nazareth Illit 17111, Israel
Cellular: +972-52-834-7893
Work: +972-4-6098629
Fax: +972-4-6564129
Email: ehud@tendomend.com


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