Ehud Almon Presents TendoMend at LSI Europe '23

Transcription

Ehud Almon  0:05  
Hello, everybody. Good morning. My name is Ehud Almon, I am the co founder and CEO of TendoMend, a tender moment we are developing a medical surgery device for treating a tendon rupture. The failsafe application or indication is for hand tendon rupture. I'm a serial Israeli entrapreneur that manage public and a private startup mainly in the medical devices area. And all this started since I'm for the last year, spending my time between Greece in Israel. And so I met a leading Greek orthopedic surgeon, Dr. valavanis that he he was the head of orthopedic department in a trauma hospital in Athens. And he developed a new suturing technique for treating a tendon rupture. So I offer him to team up. And since the ecosystem during that time, to 2018 was not so much developing Greece to move the idea to Israel. And we moved to a debt recyle I brought in to the to the company, send your engineer, which I know from the past Dr. Chu, sci fi in Kobe, Kobe blank. And with that, we founded the company, we raised the first precede the funding from a Israel Medical incubator MGT with the support of the Israeli authority innovation for the first 24 months and this is how we started. So the problem of hand tendon repair, it's actually managed for decades, by by suturing, there is no any standard technique, and they are a high percentage of complications and revision surgery. The reason for that, because on one hand, post op it's required to start early active motion or rehabilitation as soon as possible to avoid addition, because the tendons hand tendons are gliding through a tunel sheets, or it's called pulleys. And if it's not started earlier, so there will be tension and there will be limitation of the of the movements of the fingers on the Hazara. And if it's too early, so, we are or the patient is exposed for we rupture. So, to actually, we decided to concentrate is the first indication on the hand tendons, because two cells of the hands of the tendon rupture occurring in the hands. And they say the most complicated ones, even a zone two of the hands. It's a it's a name as the non mainland because it's so hard. So difficult difficult to treat. And the treatment is mainly done by by by a top a top expert or a top surgeon and a require long lead let me make care of so they say this procedure today engage with a 25% of anti satisfactory results complication is 7% of fair revision surgery, which is a consider is very high in remains unmet need in this area. So what is our solution? I'll share with you a video.

Video Playing  4:34  
In tendon repair surgery, the innovative dynamic tendon grip medical device developed by the orthopedic startup 10 domained replaces conventional surgery minimizing the high prevalence of complications associated with tendon surgery. The DTG device kit is comprised of innovative knots already and ultra high molecular weight polyethylene suture in plant with a dedicated innovative applicator and to tendon holders. The implant establishes a grip based on an external embrace of the entire tendon enabling controlled accurate approximation and alignment between the two torn tendon stops. The first tendon holder is used to grip the end of the proximal tendons and stop. Once grip, the segment is drawn into the applicator and the implant is deployed. Embracing the stump edge at a distance of five to 10 millimeters as chosen by the surgeon. The proximal stop is then released from the tendon hold. The distal tendon stomp is then treated with the distal tendon holder and applicator in a similar manner to the proximal. The two tendon segments are then connected using a unique soft join the will be locking mechanism. Once connected the implant sling tighteners are pulled drawing the two tendon segments together in a rapid highly controlled and accurate manner, allowing pre load of force fine tuning and precise alignment. This results in a robust connection between the stumps with a low profile and smooth tendon surface that enables superior gliding through the police. The deployment of the DTG implant restores the full range of motion with minimal complications.

Ehud Almon  6:36  
Okay, so it should be mentioned also that they tendon holders and the implants in our implants it's made out of sophisticate a suture notes array, or knotless array and then they these are disposable and they applicator is reusable. So we have we perform a preclinical trial in the animal model for hand tendon rupture it's two key model you can see here on the right hand a our implant and they do very well connection with attachment between the tooth and donor stamp. It's a follow up of false for weeks post op. And they actually in a pathological examination, we have shown better vascularization compared between between our implant and the suture and social solution. We perform also cadavers tries both in Israel in the US. And it's a well known as a model of a one kilo kilo gram weight in a 2000 cycles of crossing an opening day the faint gales and then a result results comparing our implant and the suture rain, we got a better gap. Because if there is more than 2 million metal gaps between the two stems, so there is no way for the connective tissue to build, it's only time a matter of time to have a real capture. So we have also better range of motion of the finger. And they they load to fellow of our implant, it's two times for having two time false, then then the suture and so it's close to 80 newtons comparing comparing 240 newtons of suturing. We have a broadened family portfolio of fourway pattern families. The first one already granted in both the USA in Europe. The regulatory past based on a thorough review done by by our a US Consultants is a 510K class two and then without the need to submit clinical trial. I am going with past about the competition. So there are two products. It's a contest that obtain FDA approval to 2014 It's a wire made out of metals in a NASA product came out from a US startup company connection to it's a kind of staple also made out of metals. The best of the one of the major benefits of our device that it's made out of suturing. It's allowed the surgeon to have perfect alignment between the two stems. And it's having low profile to allow smooth gliding through the through the pulleys. About the market potential there are close to 1 million tendon rupture cases, hand tendon ruptures cases more than an additional 350,000 cases of tendon ruptures. So we are speaking only for the first indication indication about the 1 billion US dollar or a total available market. We believe that the serviceable available market is more than half a billion US dollar. And they according to our conservative forecast will reach 50 million US dollar revenues by 2029. So a where we are on our roadmap. So following the incubator period, we raise a 1 million US dollar is a safe investment. One of the investor it's the biggest or the largest, private orthopedic body in the US in the US, it's called the Center of advanced auto Pedic. So the co founder and two hand surgeon invested the pre seed money in the company. And they actually we now we are raising raising a bridge funding of 1 million US dollar to take the company into the clinical trial phase in Israel with 10 patients and the proceeding with the FDA clearance by the end of of next year. So we are very proud of our medical advisory board. We have a US Professor Boyle, from Washington University, Professor Chang for my Stanford to ex president of the American Society for hand surgery. And we have also key opinion leaders for Europe. And for me, Israel. So what what we have now, what are the assets we currently have? We have a innovative, the device. It's a technology platform for concept in preclinical and cadaver toys, one IP experience a medical device team, we have a publication in a leading orthopedic journal. And we initiate discussion with a multinational orthopedic companies that have shown a great interest in the field because there are not too many innovation in the field of soft orthopedic tissues. So this is what we are seeking now. 1 million US dollar as a bridge funding, we said we already secure 300k And in there, that's it. So I'll be pleased if anybody has an interest, so to discuss it later on during the day. So sorry to be a little bit longer. So thank you very much.