Anat Shani, Synchrony Medical - Home-Use Airway Clearance System | LSI USA '24

Anat Shani  0:03  
Hi everyone, my name is Anat Shani. I'm CEO of Synchrony Medical, and we have developed a home use personalized airway clearance system for patients living with chronic lung conditions. So patients with chronic lung conditions need airway clearance on a daily basis to get mucus out of their lungs. Their airways are damaged full of mucus, and this is the source for repeated infections. The teacher, obviously costly hospitalizations for this condition. So the key to keeping these patients stable and away from the hospital is to clear the mucus every single day. Today, the standard of care for these patients are high frequency oscillating devices that are accessible provide therapy in the home setting, however, their efficacy is rather limited. On the other hand, chest physiotherapy can be very effective if it's delivered by an experienced physiotherapist. However, this is not scalable, there are not enough physiotherapist out there. And even if there were the associated costs are so high that no health care system can cover for that. synchrony has developed the Liberty system and Eric clearance device that imitates manual respiratory therapist technique developed at the Sheba Medical Center in Israel. They're bringing the high quality physiotherapy to the home setting making it both accessible and effective to keep the patients out of the hospital safe and and stable. So looking at this market, this is the these conditions COPD. bronchiectasis are severely increasing the awareness of the need for airway clearance on a daily basis for these patients. So they are under diagnosed and undertreated in this growing market, looking into increasing prevalence for these conditions. Looking into the EU, for example, existing devices, such as the oscillating vest are not even being prescribed and not being utilized, providing a huge opportunity for growth. Today, the oscillating vest market is led by fourth major players in this space. This is technology that's been around for over 20 years, basically vibrating the chest pounding the chest wall to get the mucus to move. These devices are highly reimbursed around $60,000 per device per home use of these patients. And companies report more profit margins high in the 70s for these conditions, and synchrony has developed a new approach for delivering their development delivering this kind of care out of the sheeple Medical Center, and I will show you our results compared to the standard of care in a second. But first, how did this work? And why is this so different? Our approach for getting the airways cleared is completely different. It is based on breathing control, we have developed the device. As you can see here in the picture, the Liberty system has compression therapy, based on synchronizing breathing with manual compressions off the chest. So we have a wearable vests applying pressure on the chest that is correlated with breathing instructions provided to the patient through our app. All of this is you can imagine the physiotherapist when they're in the room controlling the treatment So enough talking, you can see how it works. Take a deep breath. Breathe normally. Inhale, exhale slow. So the breathing instructions are provided through the app, the vest applies pressure on the chest. And when the timing was right, sorry for the graphic, but the mucus comes out. The entire idea is breathing control and to get the mucus out from the smaller airways were most effective and more most difficult to clear, all the way so they can be expelled by coughing. So our entire sorry, our vision is to take this effective treatment in the home setting, enabling patients to be stable while we're providing continuous care with their physicians with their care team, making sure they're receiving the effective treatment that they need. And as I was saying, we have performed a clinical trial comparing our device to the existing solutions to these oscillating vests. And we have shown that we were able to clear twice as much mucus compared to the existing solution that is out there today. Not only that patients report high satisfaction scores for using this device, which is key to keeping them adhering to the therapy because we're talking about chronic patients need to do it every single day, we're providing them with a solution that is much more bearable, much more effective, and one that they can commit to over a long period of time. This was led by Dr. Patrick Flume, one of the leading physicians in the space presented recently the chest conference in Hawaii. These findings strengthen the the findings of our feasibility study performed earlier in Israel. Then again we showed twice much mucus compared to existing solution and we are able to mimic an experienced respiratory therapist actually performed the treatment manually, basically validating our ability to automate this treatment. into into a device. We have some patients in Israel I didn't mention the company is based in Israel, we have some patients already using the device in the home setting for quite some time now reporting significant change in the quality of life. And this is something very, very significant for these patients imagining not being able to breathe to walk up the stairs, constantly producing mucus, with effective airway, airway clearance, we can have that stop, we can have them back into a healthy life away from the hospital, and, and continue as as they should be. Looking into a regulatory and reimbursement strategy, these are interwoven together, we're now working on a 510 K submission to be submitted this June as a class to medical device and the 510 K pathway. This paves our way into the reimbursement scheme. As I mentioned before, here in the US hickspicks code for this device is reimbursed for $16,000 per device per patient. So we're entering this market, which significant coverage for these kinds of solutions with a much more effective device. How we're going to plan to do that. Now we're looking into collaborating with leading medical centers here in the US in the space of respiratory therapy to really provide real world evidence for the use of this device. over a longer periods of time, we have collaborated with a manufacturer so a device from day one has been designed for scale up for mass production, we're working with a medical device company in Israel has a facility for production of 1000s of units per month. So we don't have to go through a way of design changes establishing a manufacturing method, we are already there ready for scale up. And we're looking to do that to partner with partners here in the US strong distribution networks, enabling us to scale up with the right team respiratory therapists there on the ground sales to really bring the solution to the market. So we have two IP families. This as I mentioned before technology license from the Sheba Medical Center, built through the medics accelerator in Israel with the support of the Israeli innovation authority, one family covers our best and one more advanced therapeutics solutions further down in the pipeline. We have a strong team medical device experience both back from the medical medics accelerator and partners, leading this company from its establishment. We are also supported by medical advisors in the space and our founding team from Shiva very involved bringing this device to where it has reached. So just to summarize, we have proven clinical results more than 50 patients already use the device shown to be twice as effective as the standard of care today, entering a market which is highly reimbursed with very high margins for such devices. And we are ready for scale up along these lines along these financials. And we are now raising our series around $5 million to support our pathway for our commercial launch in the US all the way through milestone of $1 million in revenues really showing traction showing the ability of the device to change the lives for these patients. Just to give you a sense, all what we will accomplish out what I've shown done till now has been done in three years and $2 million. So we are working very, very fast on the execution and efficiency. And we're looking to enter the space bringing the Liberty system to patients who really really need it to stay the feedback that we're hearing from patients who are participated in the trial, you know, when can I have it when I really need it, I really like it. That's a whole other story compared to the oscillating vests that are not so tolerable, not so effective. But today, that's the only solution out there. So we're really a game changer in this space and looking into wider territories outside of the US where these devices are not even being used. This is a whole other opportunity. So if you'd like to hear more if you'd like to join us on bringing this device to the market, reach out to me