Ofer Shalev | Co-Founder & CEO, New Phase | Pioneering Cancer Treatment through Breakthrough Nanotechnology

Ofer Shalev, co-founder and CEO of New Phase, shares his journey from leadership roles across high-tech, biotech, banking, and even serving as a fighter pilot, to pioneering a nanotechnology-based hyperthermia treatment aimed at transforming stage four cancer care. Ofer explains how the company’s mission focuses on prolonging life while preserving quality of life through a systemic approach designed for metastatic disease. He discusses New Phase’s progress, including treating 33 stage four patients (including at Mayo Clinic), achieving stable disease in over 60% of cases after one month follow-up, securing FDA medical device designation and IDE approval, and building a science-driven team supported by patents and peer-reviewed publications. Guest links: https://newphase.co.il/ Charity supported: Feeding America Interested in being a guest on the show or have feedback to share? Email us at [email protected].  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 087 - Ofer Shalev [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome as my guest, Ofer Shalev. Ofer is the co-founder and CEO of New Phase. With more than twenty-five years of management experience in the high-tech and biotech industries, Ofer leads New Phase operations and is pioneering a breakthrough nanotechnology-based treatment to transform the management of stage four cancer. Ofer combines deep technological insight with strategic business acumen. He previously served as CEO of several technology companies, including ReDent Nova, which led innovation in dental medical devices alongside his co-founder, Dr. Rafael Hof. Earlier in his career, he held senior leadership roles in the banking sector, including serving as VP of Operations, which strengthened his foundation in large-scale operational excellence. He holds an MBA from the University of Edinburgh and is recognized for guiding multidisciplinary teams, driving complex R&D initiatives, and scaling companies from concept to global market presence. At the core of his work is a clear mission: to redefine the future of cancer care by offering patients a safer, more targeted, and more effective treatment, one that not only attacks tumors but also preserves the quality of life. All right. Well, welcome to the show. I am so thankful you're here today. [00:02:09] Ofer Shalev: Thank you, Lindsey. Good evening. Very nice to meet you. [00:02:11] Lindsey Dinneen: Very nice to meet you too. So I would love, if you wouldn't mind starting off by just sharing a little bit about yourself, your background, and what led you to medtech? [00:02:25] Ofer Shalev: Well, I would say that during the year, I had extensive managerial experience across many multiple sector, including industry, high-tech, banking, and obvious-obviously life science. I have also to mention that about fifty years ago, in my experience I was a fighter pilot, pilot in the Israeli Air Force. It was, again, about fifty years ago. I would say that it probably significantly shape who am I today. I mean, it's developed my ability to to take a calculated risk, for example, or to act quickly and precisely to plan ahead, to build contingency plans. So all that kind of thing that probably was very relevant to the time I, I w- I used to serve in the Israeli Air Force, but also very relevant to the, to the industry. Okay? And furthermore, I would like to say that probably I am highly motivated by challenge. It, it's make my day. In addition, I am a father to four children and a grandfather of seven grandchildren. And I do hope that at the end, I will have about twelve grandchildren. So, the kids have still to work about it. Yeah. And I would say that you asked about myself, so probably I have a very, very strong belief in the path, in the way that I'm choosing. It's I would say, enabl-enabling to, to overcome about the difficulties, mainly when you're looking for challenge, especially in, in a new and unfamiliar field, like in our case of New Phase And furthermore, I, I, I, I truly believe in the word "never give up." You will find solution to everything. Never give up. I like very much as I mentioned before, to, to meet a challenge and to overcome our challenge many times by breaking some problem into pieces and then to assemble it again. Furthermore, I would say we, we met many, many problems in our life. I, I think that we have to focus about the solution, not about the problems. You cannot change problems. It's happened. But let's try to find and, and to think about how to find the right solution to it. And I would say that I, I f- I feel very, very, very good to to operate or to, to function in a turbulent area. I mean, I like it very much. I, I know that not, not, not anyone like it, but I feel very good in, in this area. [00:04:59] Lindsey Dinneen: Wonderful. Well, thank you for sharing a bit about your background. I have so many questions, but I would love to actually learn about what you're doing right now with New Phase, because I know you're passionate about it. There's, there's a lot that goes into cancer research and treatment, and I know that that's been such a challenge for so many years, and I love the fact that your company is really diving into that challenge and tackling it. And I was just wondering if you could explain where the concept of New Phase came from, and what exactly makes your company so unique in this space? [00:05:39] Ofer Shalev: So the, the idea came that it was 14, 14, 15 years ago, while me and my partner, Dr. Rafael Hof, we were involved with some other company, and after that at that time his mother, her name was Sarah, she wa- she had lung cancer. She passed away. And during that time, we have a very, I mean, many time conversation about the disease. No, no, no, none one, none one of us is, was oncologist, okay, by training. But we have many, many discussion about the treatment what are the relevant treatment that are available, et cetera, et cetera. And after she passed away we, I mean, Rafi, who is a great technology guy, came with this idea of nanoparticles and hyperthermia, and we start to work about it. Again, we have to learn, both of us, we have to learn a new area of technology, of biology, of chemistry, of physics, engineering, regulation, everything. And it was not only that we have read and learn about it, but we decide al-also to, let's say, to, to jump into the pool, into the water. We put each one of them, each one of us put some money. We hire some chemist. We also hire from one of the university in Israel some space. Like you, I mean, usually, I, I believe it's the right way to develop a company. I mean, to start and building it, the company, in the garage, okay? Right. And, and, and sure, you have, you have to-- you cannot just think about it, you have to, to, to do something. And the outcome was actually the proof of concept. We show in the in vitro, under microscope, how some very, very primitive nanoparticles were being irradiate, caused damage to the cancer cells. And that was the time that we founded New Phase. I truly believe that it's the right approach that first you have by yourself to, to deliver, to show the proof of concept, then go to investor and try to convince them to, to invest in your in your company. So that was what we have done. It was a very, very long way. I mean, the company was founded just 13 years ago. The vision didn't change. I mean, from the beginning, the idea was to prolong life of cancer patient, and in order-- and in addition to maintain the quality of life. At that time we used the word of chronic treatment or managing the disease, and many of the people that we met, skeptical one said, "But you, you don't cure the disease." So we explained that as we see in the next twenty years, nobody will cure the disease, but for the meantime, people have to live. [00:08:35] Lindsey Dinneen: Hmm. [00:08:36] Ofer Shalev: Now, the vision is still today. It was implemented into a technology. But yes, the technology was changed several time along the year, but the vision is still here, and that is, that is the, the outcome as of today. We already treated thirty-three patient with stage four, six of them in a Mayo Clinic, very distinguished hospital. I mean, I would say ranked number one worldwide. A great cooperation with them. I would say that till the summertime, we will treat another six patient, and after we move to the feasibility study, where we will have to choose few indication, and we will add another to a US hospital to join to the feasibility study. It become a product. As I mentioned, we treated already thirty-three patient. We have about fourteen patents that already granted. We have about, since we are-- we truly believe that we are in a deep science company, so we truly believe in the, in the scientifics based evidence, and we already publish nine peer review scientific articles. We have done a lot of work and success with FDA. First, and again, it was a breakthrough idea to, to succeed and get designation of medical device. Although we inject infused nanoparticle into the body, but we convinced the FDA that although we infuse nanoparticle, hence our mode of action, primary mode of action is actually engineering one or physical one, and therefore we were, we were designated as a medical device, which again save a lot of budget and, and time while reaching to the clinical study. And then later on, we got the IDE, I mean, the, the approval to start clinical study in the US. So we have done a very, very long way, and I would say that it's very satisfying while seeing today that first of all, we have a product, not only idea, and the vision is still here. I mean, what we can see that we... many of the patient, although it in the early feasibility study, and the main goal is to achieve safety and to show it's non-toxic. So even though we succeeded in more than about sixty percent of the cases we treated in nine different indication of cancer to reach to a stable disease. Let's say after one month of follow-up, the tumor metastasis are the same size, and there were no new lesion during that time. So, yeah, we-- I would say that it start, it start-- it seems that we start to reach to the, to the real game in the feasibility study where we will focus about two to three indication, and the idea is to treat patient for at least, let's say, six months, and to show that we can, we can keep them in a status of stable disease. [00:11:44] Lindsey Dinneen: Yeah. [00:11:45] Ofer Shalev: Further, furthermore, all the patients that we got, all of them are metastatic stage, let's say stage four, which exhausted all other treatment. So many time, you can see that in the retrospective data, before the joining to the study, the tumors or metastases have a progression rate of so and so percent per month, and after our treatment is dramatically reduced or even stopped. So, a lot of enthusiasm with the current status. [00:12:18] Lindsey Dinneen: Yeah, a lot of enthusiasm and a lot of hope. I, I love what you're doing because, yeah, as you said, I mean, at that point, people probably feel so stuck and hopeless. And so to be able to learn that there is technology that is being actively worked on that can... [00:12:36] Ofer Shalev: Yeah. [00:12:36] Lindsey Dinneen: ...really help them [00:12:38] Ofer Shalev: Yeah, yeah. We are-- you also ask what, what we-- what, what is the difference that we bring to the market? [00:12:42] Lindsey Dinneen: Mm-hmm. [00:12:44] Ofer Shalev: So the hyperthermia is well-known for many, many years to be a useful way to treat cancer. Okay? Because cancer don't have resistance to hyperthermia. And let's skip about all the biology factor, but this is a well, well-written evidence in, in the literature. So, but usually all the current hyperthermia methodology is a local treatment, meaning you have to define where the tumor is, CT, MRI, whatever, and to try, try to heat this tumor either by infrared or with-- or inject directly nanoparticles into the tumor, et cetera, et cetera. What we are offering is a totally a new approach of treating systemically in tumors at stage four. Let's say in many cases, you don't know even where the tumors are in the volume of treatment, meaning we treat the torso area. It's not that we are trying to find tumor by tumor. No. We're treating the whole area of the torso, and by that we can destroy the tumor, which in stage four are localized in, in different area in it. So this is one thing. The other thing that I would say that the stage four mainly people that exhausted other treatment is really can be considered as a unmet need. And that's, that's the population that we are focused about. That, that's the population that we are focused about. [00:14:11] Lindsey Dinneen: Yeah. Yeah, that is really incredible to hear. I, I love what you're doing. I'm curious, as you've gone about this process and f- you know, 13 years worth of learnings and growing as a company, what is something that's really surprised you along the way? [00:14:34] Ofer Shalev: Surprise? Well, you know, I said before, when, when you, when you start this this journey with a deep s-- belief in yourself and in your team, you're not really surprised. [00:14:49] Lindsey Dinneen: Hmm. [00:14:50] Ofer Shalev: Yeah, I mean, no, there is a lot of surprise. I mean, we, we went in an area which nobody stepped before in the, in those days. Nobody stepped before. But I would say it was obvious to me at least that okay, we are thinking about the right approach. We are trying to find our way. We invest a lot about trying to read whatever is relevant. We are speaking with oncologists, learn from them in many time about the failure, and try to make sure not to do it. So I'm not surprised. I'm very happy. And again, it's not... It was not by accident. On one hand, a very strong belief, and on the other hand, in-depth learning every piece of knowledge that we were able to collect [00:15:33] Lindsey Dinneen: Yeah. Yeah, that's so important, and I appreciate you saying it that way. I think intentionality is such a key component of leadership, and this is some of the conversations that I'm enjoying having lately is, h- and I'd love to get your input, is how do you go about intentionally creating the right team, the right vision, and the right culture to support the fact that you don't have to be surprised by things? You get to be happy, but you have the right framework in place. [00:16:08] Ofer Shalev: So I would say that in terms of the team, it was changed and replaced along the way. [00:16:15] Lindsey Dinneen: Mm-hmm. [00:16:17] Ofer Shalev: At the beginning... By the way, even today we have we have, we have twenty-four employees. Six of them are PhD Along the way, since we need people that know how to read articles, how to analyze article, et cetera. So I would say that we have in a, in a, in a company of about six, seven employees, three or four of them were PhD. There was a lot of self-learning to do. Later on, we start to make, "Okay, we have to develop. We have to build a product." So obviously, we, we, we mixed this team with people that came f- with some experience from the industry. Furthermore, experience from the medical device industry. Okay? So I would say along the time the, the, the population in New Phase become to be more heterogeneous. [00:17:08] Lindsey Dinneen: Hmm. Mm-hmm. [00:17:10] Ofer Shalev: Because really we-- you-- I mean, currently we have a product, so we need people about regulation, about quality, people that know very well engineering, people that have a idea about operation and not only researcher. But again, at, at the beginning, all, all our employee came from the... I mean, we, we, we, we re recruit about I think three or four PhD at the beginning to start with, and it will change along the way. Yeah. Now about-- you ask about leadership. So, I would say that I ca- I can see the leadership not only about, about leading people, but also about pushing your vision. Okay? Because again at the beginning, an idea of changing the cancer disease into a manageable disease, it was not so well accepted idea. Anyone ask about curing, but we keep saying, "No, there is no, there's no g- currently, there's not a real good chance of curing. Let's focus about prolonging life." Nowadays, it's common language. You can see from any, any drug company discuss the issue of manage- manageable disease. But when we start with this vision, it was very hard to convince people about it, and obviously many of them said in a very skeptical way, "You will not make it." [00:18:29] Lindsey Dinneen: Mm. [00:18:29] Ofer Shalev: So this part of the leadership as well, "Okay, I heard you. Let's, let's meet at the end of the day and we'll see what hap- who, who is the right one." So, yeah. So I would say that in our case, leadership is, is mainly to, to maintain the vision, to push the vision, to develop the vision. Partially it's about, a- about employees, sure, because at the end you have to recruit employees that will implement this vision into a technology, into a product But I would say that in a company like New Phase, the, the leadership is as more than 50% is about the vision. [00:19:11] Lindsey Dinneen: Yeah. Yeah, pushing the vision forward. I, I really appreciate that. I, you know, you had so many things at the beginning that you were talking about that I really appreciated. You talked about never giving up, overcoming difficulties, and loving challenges, and I think all of those are critical, of course, as an entrepreneur. But I'm also particularly curious about your h- you mentioned that you break down challenges into pieces and then rebuild, and I'm curious, where did that philosophy come from and how do you practically implement it? [00:19:48] Ofer Shalev: Frankly speaking, I don't know from where it came. No, I don't know. I mean, you know, with... Du-during the way, I, I, I had many, many chance to, to, to rethinking about some problem that we solved, and I asked myself, "How the hell we know what to do?" I, I don't know, frank- In, in many times, I would say that main-ma-mainly because we try to simplify the problem to pieces, and then we have a breakthrough id-idea about it. It is not-- I mean, the methodology is about breaking the problem into pieces. How to assemble it again, this is a breakthrough. I don't know how to explain it. [00:20:32] Lindsey Dinneen: Okay. [00:20:33] Ofer Shalev: really. [00:20:33] Lindsey Dinneen: Yeah, but do you find that maybe taking it apart and so probab- maybe part of it is, I wonder, you know, when you've got a challenge, it feels big and insurmountable, and you can't make any progress versus if you break it down and you go, "Okay, yeah, maybe this as a whole feels t- like too much, but what about this one little piece that if I can overcome this, then it will push me forward in overcoming the ultimate challenge?" I wonder if it's partly... [00:21:02] Ofer Shalev: It, it, it might be, it might be the situation. It's simple to, to deal with a, with a simple or with a, with a partial challenge, partial partial problems. And then it says, "Okay, I, I, I solved this issue. Let's try to solve another issue." And all of a sudden, you figure out that, "Hey, I have the full picture. I solve it." [00:21:23] Lindsey Dinneen: Yeah. That's, that's really cool. Okay. So, you know, you've had an amazing career, and not just within this space of course, but before that, and I'm just wondering if maybe especially along this particular journey with New Phase, are there any moments that really stand out to you as affirming, "Wow, I am in the right place at the right time in the right industry"? [00:21:54] Ofer Shalev: Yes. I, I, you know, I, I think that it's... No, it will, it will par-- it will par-- I, I will answer you partially. I mean, once we decided to founder the company and that myself and my partner, Dr. Rafael Hof, we have after another company that we, we had, and we-- And when he came with this idea, I thought to myself, "If there are two entrepreneur worldwide that are able to deal with that problem, it's probably the two of us." Yeah. Ab-absolutely. Yeah. [00:22:31] Lindsey Dinneen: Yeah. [00:22:32] Ofer Shalev: Because the way that we work together, the w- the way that we each one of each one of us cover different area, how to build this kind of a crazy idea. I would say that really just only, you know, two people that are crazy enough and can work so well together can deal and succeed in this task. So this is the kind of, of, of of memory that I have from the beginning of the company. [00:22:57] Lindsey Dinneen: Yeah. I love that. That's, that's really cool. You, you know, you mentioned also at the beginning that some of your experience as a pilot was really critical in helping you learn different skills or disciplines that help you succeed throughout your career and today. Do you mind just talking a little bit more about some of the things that you still hold onto as really important lessons learned? [00:23:24] Ofer Shalev: Okay, know, to be in a, in a cockpit of a fighter i-- of a, of a fighter airplane, I mean, just ones that was there can, can understand what I'm speaking about. But it's a who- the whole way of thinking. So I would say that from time to time, when I have quite, quite a big challenge, I, I, I imagine to myself that I'm in the cockpit, okay? In order to, to think the same way that you used to think fifty years ago. Okay? Now with, wi-with, with regarding with regarding it to to some advice, okay? To to some to some other entrepreneur, let's call it this way. So, I would say that first of all, choose a real breakthrough idea. Not an idea that, okay that probably someone else did before or will do it after-- will, will make it after you. Try to find a real breakthrough idea to... Because, you know, at the end, you, you sacrifice a, a big piece of your life about it. [00:24:24] Lindsey Dinneen: Mm-hmm. [00:24:25] Ofer Shalev: So try to find something which is real, real something. This is one. Then you have to have a very strong backbone and remain committed to your vision. Yes, you might change the technology, that's okay, but you have to be committed to your vision. And furthermore, probably many times along the way, you will hear from people you will not succeed, it's the wrong way, et cetera, et cetera, et cetera. So nowadays, when I hear this kind of a voice, I say, "Why don't you open the startup of yourself? If you know it so well, why don't you open? Because you don't have the courage?" [00:25:06] Lindsey Dinneen: Mm-hmm. Mm-hmm. [00:25:08] Ofer Shalev: And yes, courage is, is, is, is another component which is very important to entrepreneur that choose a way how to change the world. [00:25:18] Lindsey Dinneen: Mm. Yeah. I love that. Thank you for sharing. Okay, so pivoting the conversation a little bit just for fun, imagine that you were to be offered a million dollars to teach a master class on anything you want. Could be within your industry, doesn't have to be. What would you choose to teach? [00:25:40] Ofer Shalev: I don't know how to do it, but I will say it in other ways. I probably to, to, to, to teach people how to avoid or what to do while you are in a dead end. [00:25:52] Lindsey Dinneen: Hmm. Okay. Do you wanna elaborate a little bit? 'Cause I'm curious. [00:26:00] Ofer Shalev: I think that, that, that your ability really to believe in yourself is a key factor. [00:26:05] Lindsey Dinneen: Mm-hmm. Mm-hmm. [00:26:06] Ofer Shalev: Your ability to, to free your mind, not to focus about the current problem, but to free your mind, going outside and try to find some other idea is quite important one. [00:26:18] Lindsey Dinneen: Yeah. [00:26:18] Ofer Shalev: Yeah, those kinds of things. Probably we have to think about this kind of a masterclass. [00:26:23] Lindsey Dinneen: That would be a great masterclass, yeah. Okay. All right. [00:26:27] Ofer Shalev: By the way, I, I truly believe that in order... I mean, at least that's what I'm doing. But I, I besides that I'm working very hard, I try to read many books. It might be biography, it might be historical novel, it might be by... it might be a thriller. I try to be very, very diverse in what I am reading. I believe it's, it's just fruitful my mind, and not to focus about only about some scientific articles. [00:26:56] Lindsey Dinneen: That's... I love that. That's great. All right. And how do you wish to be remembered after you leave this world? [00:27:06] Ofer Shalev: Well, it's not something that I particularly concerned about it, truly. I don't, I, I don't... I, I, I will say fir- I will say something else. I truly believe that true leader are not focused about what people will remember about them. It is important that the vision will stay. It's important that a father and mother, or children that have cancer in the family will be able to live longer life with a better quality of life. It's much more important if people know, "Hey, Ofer Shalev bring this technology to the market." [00:27:45] Lindsey Dinneen: Mm-hmm. [00:27:46] Ofer Shalev: That, that the way I see it. I mean, I don't care too much what will people remember after I leave this world. [00:27:53] Lindsey Dinneen: Yeah. No, that's, that's beautiful. I love that. Okay, and then final question: What is one thing that makes you smile every time you see or think about it? [00:28:04] Ofer Shalev: Well, that is very, that is very easy. You know, when you have so many, so many grandchildren, so, to hear the questions "Why did, why did it happen?" "Why the bird is flying so high?" The, the truth and simplicity of children and the way that they are thinking, that's really something that make, I think, everybody smiling about it. [00:28:28] Lindsey Dinneen: Yeah. That's so fun, and I couldn't agree more. I I have a few nieces and a nephew, and getting to, to sort of see the world again through their eyes and perspective is just really fun. It's just, it's joyful. [00:28:44] Ofer Shalev: Yeah, it's a great chance to hear about a simple way of, of how the world should, should be. [00:28:49] Lindsey Dinneen: Yeah. Curiosity. I love the never-ending curiosity. [00:28:52] Ofer Shalev: And asking many questions. It's very-- I mean, asking question is, is a great, is a great benefit. [00:28:58] Lindsey Dinneen: Yes. [00:28:58] Ofer Shalev: Ask as many questions as you can. [00:29:00] Lindsey Dinneen: Your whole life. [00:29:01] Ofer Shalev: Yeah. [00:29:02] Lindsey Dinneen: Yeah. Excellent. Well, this has been such a great recording. I really appreciate you sharing your your vision especially about New Phase and where you hope that the company will go and, and the lives that it'll impact. And I know you're well on your way, and I just wanna thank you for not listening to the people who said, "This is not gonna happen," or were trying to discourage you. I'm just so thankful that you're doing what you're doing. And we are honored to be making a donation on your behalf as a thank you for your time today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger, and they also advocate for policies that create long term solutions to hunger. So thank you for choosing that organization to support. So, really appreciate you being here today and just really appreciate everything you're doing to change lives for a better world. [00:30:00] Ofer Shalev: Thank you very much, Lindsey. [00:30:02] Lindsey Dinneen: All right. You too. Bye. [00:30:04] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. 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