Transcription
Angela Liedler 0:05
Hello, everybody. Thank you very much for having me here. My name is Angela Liedler, I'm CEO of Precisis, and I'm really proud to share our success story with you. Let's talk about E let's talk about easy. A new bio electronic therapy for patients suffering from epilepsy. EASEE is the world's first minimally invasive brain pacemaker for the treatment of epilepsy that has entered its commercial phase. And now it's all about growth. We are almost finishing our series B round of 14 million. And if you are interested in bringing in 5 million you're warmly invited. But first, let me introduce our innovation with you to you. Think we need some sound
Video Playing 1:10
treated with medication. The thin electrode mat of the easy system is implanted through a small incision under the scalp. Over the area of the brain affected by epilepsy, the head bone remains intact and the brain untouched. A thin stretchable cable is inserted under the skin to the pulse generator located on the chest muscle. The complete easy system works invisibly under the skin. The pulse generator sends electrical signals through the head bone to the brain via the stimulation electrode. They interrupt emerging focal seizures as well as stabilize the brain permanently over time. Easy is set from outside by the treating neurologist through a programming device, the physician can adjust the stimulation parameters to the individual needs at any time. Patients themselves can also communicate with the system using a handheld device. Easy, easy to place, invisible, easy to use, individually controlled, easier living with epilepsy.
Angela Liedler 2:40
Well, there's an outstanding technological innovation behind that. As you see it is minimally invasive, it is highly precise and personalized treatment for patients suffering from epilepsy. The device is delivering two modes of action a high frequency pulse stimulation for interrupting upcoming seizures and the DC like mode for 20 minutes each day for preventing seizures for sort of a neuro modulation effect. But all the technology behind that is only for one reason it is for easing the lives of patients and you see all these green men. These should represent 84% of all patients who benefited in our clinical trials. And this is something that made us very proud. The four dark people they got completely seizure free and gained a new positive life. We are quite well protected, protected with our patents all over the world. When it comes to competition, one has to say once a person is diagnosed with pharmacoresistant epilepsy that means that this person cannot be treated with medication, then surgeons tend to just cut out the impaired brain area like butchers, honestly, I mean, this is our main competitor, the neurosurgeon that like to cut out with a crude procedure. The next one is the RNS System by neuropathy is only available in the US very good efficacy, but a little bit poor safety profile because it's a huge surgery needed Deep Brain Stimulation procedure and Vagus Nerve Stimulation not as good in efficacy and therefore we would like to compare to the RNS System and the resective surgery with a far better safety profile. And this is why we want to like to position our easy device as first choice and so called drug refractory epilepsy patients. What have we achieved so far? So the idea was born so seven years before we started in 2015, we looked for seed investors and raised a Series A of 20 million. And then we partnered with Cochlear limited in 2021, with another 16 million of investment. And with this money, we conducted all our animal and human trials that led them to the CE mark in adults according to the MDR, by the way, and now we are raising another 40 million in series B. A part comes from the European Investment Bank, the other part from existing shareholders and new investors. With this money, we would like to develop our next generation product this is EEG tracked and AI based. And we would like to conduct the US pivotal study to get FDA approval in 27. Besides that, we certainly would like to scale up the European market. By the way, this year is the first one, we have revenues we will have 50 implantation in Germany, Switzerland and Austria by the end of the year. 1.4 million people are eligible for EASEE and we counted like that 6.5 million is suffering from epilepsy, little less than 1/3 are drug resistant. And in 70% of them, you can see the origin of the of the seizures, the epileptic focus. And this is exactly the location we put our electrode on. And as I said, we had our first revenue this year, and we will be scaling up throughout the year of next year with the first 6 million revenues. And then in 2027, we are adding the US revenues and jumping over the threshold of 100 million in 29. So together with the revenues and the 40 million here is the overview of the use of our proceeds is the European market growth is the US approach is a new generation development. And last but not least, very proud next year, q1 will be the kickoff of our next indication that will be patients suffering from major depression. Nothing could have been done without my team. Michael, our Chief Technology Officer is here with me, you can recognize him because he has exactly the same T shirt with our brand easy so please don't hesitate to approach Him or me for further questions. Pefor Marcus. He's very experienced in commercialization. He will expand our markets, he builds up our sales team. So whenever you feel that you might be a good partner in terms of sales and commercial. Please get in touch with us, Joe and PC. They are heroes in regulatory and medical affairs, and Gabi is our marketing manager. We are 26 people in Heidelberg. Growing up to 50 this year. We have one very good testimonial Ebro him suddenly he's not an employee but a patient but he lives as a neighbor to us. He was the very first patient who got completely seizure free by our treatment. So whenever you like to see a patient video, just look at our website. By the way this year we won the Shark Tank competition with the Epilepsy Foundation diversion in Miami. So now we are really on the radar and we are proud of everything what we have achieved and very excited to get in contact to you. Thank you
Angela Liedler, MD, is a serial entrepreneur. After selling her healthcare agency in 2011, she transitioned to the MedTech sector and took over majority at Precisis. She is one of the inventors of EASEE® and raised capital for a Series A round. Under her leadership EASEE®, world´s first minimally invasive brain pacemaker for the treatment of focal epilepsies, developed from an idea into a product gaining CE approval under MDR. Next steps for EASEE® and Angela include entering various European markets and achieving FDA approval.
Angela Liedler, MD, is a serial entrepreneur. After selling her healthcare agency in 2011, she transitioned to the MedTech sector and took over majority at Precisis. She is one of the inventors of EASEE® and raised capital for a Series A round. Under her leadership EASEE®, world´s first minimally invasive brain pacemaker for the treatment of focal epilepsies, developed from an idea into a product gaining CE approval under MDR. Next steps for EASEE® and Angela include entering various European markets and achieving FDA approval.
Transcription
Angela Liedler 0:05
Hello, everybody. Thank you very much for having me here. My name is Angela Liedler, I'm CEO of Precisis, and I'm really proud to share our success story with you. Let's talk about E let's talk about easy. A new bio electronic therapy for patients suffering from epilepsy. EASEE is the world's first minimally invasive brain pacemaker for the treatment of epilepsy that has entered its commercial phase. And now it's all about growth. We are almost finishing our series B round of 14 million. And if you are interested in bringing in 5 million you're warmly invited. But first, let me introduce our innovation with you to you. Think we need some sound
Video Playing 1:10
treated with medication. The thin electrode mat of the easy system is implanted through a small incision under the scalp. Over the area of the brain affected by epilepsy, the head bone remains intact and the brain untouched. A thin stretchable cable is inserted under the skin to the pulse generator located on the chest muscle. The complete easy system works invisibly under the skin. The pulse generator sends electrical signals through the head bone to the brain via the stimulation electrode. They interrupt emerging focal seizures as well as stabilize the brain permanently over time. Easy is set from outside by the treating neurologist through a programming device, the physician can adjust the stimulation parameters to the individual needs at any time. Patients themselves can also communicate with the system using a handheld device. Easy, easy to place, invisible, easy to use, individually controlled, easier living with epilepsy.
Angela Liedler 2:40
Well, there's an outstanding technological innovation behind that. As you see it is minimally invasive, it is highly precise and personalized treatment for patients suffering from epilepsy. The device is delivering two modes of action a high frequency pulse stimulation for interrupting upcoming seizures and the DC like mode for 20 minutes each day for preventing seizures for sort of a neuro modulation effect. But all the technology behind that is only for one reason it is for easing the lives of patients and you see all these green men. These should represent 84% of all patients who benefited in our clinical trials. And this is something that made us very proud. The four dark people they got completely seizure free and gained a new positive life. We are quite well protected, protected with our patents all over the world. When it comes to competition, one has to say once a person is diagnosed with pharmacoresistant epilepsy that means that this person cannot be treated with medication, then surgeons tend to just cut out the impaired brain area like butchers, honestly, I mean, this is our main competitor, the neurosurgeon that like to cut out with a crude procedure. The next one is the RNS System by neuropathy is only available in the US very good efficacy, but a little bit poor safety profile because it's a huge surgery needed Deep Brain Stimulation procedure and Vagus Nerve Stimulation not as good in efficacy and therefore we would like to compare to the RNS System and the resective surgery with a far better safety profile. And this is why we want to like to position our easy device as first choice and so called drug refractory epilepsy patients. What have we achieved so far? So the idea was born so seven years before we started in 2015, we looked for seed investors and raised a Series A of 20 million. And then we partnered with Cochlear limited in 2021, with another 16 million of investment. And with this money, we conducted all our animal and human trials that led them to the CE mark in adults according to the MDR, by the way, and now we are raising another 40 million in series B. A part comes from the European Investment Bank, the other part from existing shareholders and new investors. With this money, we would like to develop our next generation product this is EEG tracked and AI based. And we would like to conduct the US pivotal study to get FDA approval in 27. Besides that, we certainly would like to scale up the European market. By the way, this year is the first one, we have revenues we will have 50 implantation in Germany, Switzerland and Austria by the end of the year. 1.4 million people are eligible for EASEE and we counted like that 6.5 million is suffering from epilepsy, little less than 1/3 are drug resistant. And in 70% of them, you can see the origin of the of the seizures, the epileptic focus. And this is exactly the location we put our electrode on. And as I said, we had our first revenue this year, and we will be scaling up throughout the year of next year with the first 6 million revenues. And then in 2027, we are adding the US revenues and jumping over the threshold of 100 million in 29. So together with the revenues and the 40 million here is the overview of the use of our proceeds is the European market growth is the US approach is a new generation development. And last but not least, very proud next year, q1 will be the kickoff of our next indication that will be patients suffering from major depression. Nothing could have been done without my team. Michael, our Chief Technology Officer is here with me, you can recognize him because he has exactly the same T shirt with our brand easy so please don't hesitate to approach Him or me for further questions. Pefor Marcus. He's very experienced in commercialization. He will expand our markets, he builds up our sales team. So whenever you feel that you might be a good partner in terms of sales and commercial. Please get in touch with us, Joe and PC. They are heroes in regulatory and medical affairs, and Gabi is our marketing manager. We are 26 people in Heidelberg. Growing up to 50 this year. We have one very good testimonial Ebro him suddenly he's not an employee but a patient but he lives as a neighbor to us. He was the very first patient who got completely seizure free by our treatment. So whenever you like to see a patient video, just look at our website. By the way this year we won the Shark Tank competition with the Epilepsy Foundation diversion in Miami. So now we are really on the radar and we are proud of everything what we have achieved and very excited to get in contact to you. Thank you
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