Marco Pisano Presents Lymphatica Medtech at LSI USA '23

Transcription

Marco Pisano  0:05  

Thank you. Thank you for for the kind introduction. I'm Marco Pisano. Again, I come from Switzerland. Lymphatica is a Swiss company was founded in 2017. And is really focused on one main unmet medical need which is lymphedema. Great so as as you said, we are a clinical stage company. We produced a first in class cluster free permanent implant for the treatment of chronic lymphedema. We want to disrupt a $5 billion addressable market with a breakthrough solution, which is called Lympho Drain. We have positive initial clinical evidence we have completed just completed the first Imen clinical trial with nine patients in blunted and we have done this very, with a very short budget, we have raised approximately 4 million $5 million in equity and convertible loan to now. We are now raising a Series A or $50 million this year. But first of all, what is lymphedema? Lymphedema is a swelling is a chronic swelling of the arm of the legs or other parts of the body. It is mainly due to a damage of the lymphatic vessel network. It's a it's not a rare disease, which comes often as a side effect of successful cancer treatment but also other types of injuries that can affect the lymphatic system is not only aesthetic condition, but comes with pain recurrent infection, but it's very important to know that as of today, there is no existing cure for this disease. And again, is not a rare disease there are approximately 10 million patients estimated between European us with this condition. As of today, the standard standard of care is solely so called complete decongestive therapy, just Compression Compression meaning author done at the office of the physiotherapy with manual drainage is and then a series of bandages that the patient has to do with double triple bencher depending on the situation and then most importantly, compression that the patient's this garment of the patient has to wear, sometimes 24/7 for the rest of their life. So you can see how the current treatment the current treatment, it gives a lot of problems for the patient, it's really entails a changing lifestyle for the patient, and significantly affects the quality of life. So patients say being compression free would be would mean the word to me. So really meaning that the compression is really the main pain point for those patients. So at Lymphatica we said how how can we give the patient the possibility of living without without any compression without affecting the lifestyle? And the answer is acting from under the skin. We develop what is called leaf drain the first artificial lymphatic lymphatic bypass it's it is actually a subcutaneous catheter linked with a microbiome both implanted under the skin. The catheter in the microbiome what they do, they move the fluid lymph fluid from the subcutaneous tissue in the arm or in the leg upwards until the central part of the body when then Where then is recirculated in the blood circulation. The micro pump is very small and can be so small because there is no electronic nor any battery inside. But it works thanks to magnetic coupling with a wearable bracelet that the patient wears on top of their skin. The device is also connected in the cloud so that the doctor remotely can set up the configuration of the pump itself. So meaning flow rate and amount of hours per day the patient should should have this pump functioning. But let me show you a little bit how it works. So the SIRT the procedure is very simple. The surgeon makes a little cut at the level of the shoulder for r&d Fatima case than with the standard tunneler insert minimally invasively the catheter under the skin no connection with any vessel needed. Same thing is for an output catheter and then close all the sutures and it's done. So when the patient's wears their wearable controller and presses a button than the pumps are working absorbing fluid all over the length of the draining catheter bringing it in the subcutaneous tissues in the central part of the body where there is reabsorbed by the local functioning lymphatic vessels and veins. We have two versions of the pipeline one for arm and one for legs. And again as I said we are addressing a very large addressable market size up process is estimated to be $5 billion. And this only entails one segment of the total patient lymphedema population, only the so called moderate lymphedema and European US. We have for this segment, we have a prevalence of about 2 million patients and an incidence of 180,000 patients per year. Where are we now? So in the last five years, we progress until first in human trial. So we have secured our IP licenses. We are an ISO 1345 certified company. So quality management system fully in place, we have had our seed round 2020. And yes, now we have just completed nine patients implementation for our first demand clinical trial. We are the FDA pre submission meeting last year to really validate our clinical clinical strategy going forward. But talking about our clinical results, well, big again, our device is the first inkind clinical medical device. And as such, we had really astonishing preclinical clinical result, we had no serious adverse event. And we've demonstrated for the first time that patients with our device don't need to wear any more any compression nor doing any manual drainage is we have shown the lym flow in our device in and out. And we have monitored the limb volume showing that with our device, actually the volume volume could actually be diminished respect to compression, our volume. So most importantly, we had the feedback from our patients. They said, wearing having your our implant was meaning freedom for us. They said it was exceptional. Most importantly, they said I would I would continue with with this device I'm ready to start again. The clinical outcome is also very significant according to our key opinion leaders that confirm how really being compression free is on top of being what patient wants means actual a significant clinical outcome. So as of today, we are raising a Series A of $15 million and this is to finance first of all, pre production and vnv of the next iteration of device for market ready the market ready device. And most importantly, the people that clinical trial will be will be a multicenter pivotal clinical trial ID clinical trial between Europe and US with the total time follow up of two years that will bring us to FDA approval in 2027. Our exit strategy is a trade sales to Corporation active in peripheral vascular implant, specially the one active with the Venus implant in their portfolio. Regarding the team we are seven full time employee in the company we have a management team with many years of experience in many of the corporation active in peripheral vascular meaning maytronics or Northrim. Edwards, we are advised by a top notch Key Opinion Leader in our clinical advisory board with the professor bucardo, which is the President of the European Society of lymphology. And Professor materiali with with the president of lympho Suisun of the European vascular society. But so emphatically we won't stop here live lymphatic system, the lymphatic system as it's been on the on the news in the last few years, where it's clear how it's involved in many not only in lymphatic in lymphedema, but in many other diseases and name like neurological diseases or musculoskeletal diseases. So in fact it has platform as a huge potential to go forward. So if you're interested to continue to invest in us and to be part of our journey, please contact me. Thank you