Some entrepreneurs leave a legacy not only for their inventions but also for the heart they put into their work. Such is the story of Parag Gad, the co-founding CEO of SpineX, which is a clinical-stage bioelectric medtech startup doing more than just pushing boundaries in healthcare. With groundbreaking, non-surgical devices that improve neurological conditions, Parag and his team at SpineX are genuinely improving the quality of life for adults and children struggling with debilitating conditions like spinal cord injuries, stroke, and cerebral palsy.
Despite being formally trained as a biomedical engineer, Parag’s real mastery lies in neurophysiology.
His venture into entrepreneurship came after 12 years of rigorous training in neurophysiology at UCLA. With over 15 years of experience in both preclinical and clinical research and product development, Parag's ambition to transform basic science into life-changing products materialized with the launch of SpineX in 2018.
After laying a foundation steeped in research and development, SpineX is championing two groundbreaking products, SCONE and SCiP, which are both extensions of their same platform technology but solve different problems in different patient groups.
SCONE assists adults suffering from neurogenic bladder while SCiP is designed to serve children struggling with cerebral palsy by improving their sensory-motor functions. Both devices leverage the power of spinal neuromodulation to improve patients’ life quality. What separates these from other interventions in this space is their non-invasive, non-surgical, and thus painless nature, and their ability to induce long-term neuroplasticity.
As Parag explains, “You wear it for an hour a day, a couple of times a week, and you're able to induce what's called neuroplasticity in the brain and spinal cord. So the improved function that you're observing is not only present when the electrical neuromodulation is actively delivered, but you're actually causing changes in the organization of the brain and spinal cord, allowing them to retain function even in the absence of active stimulation.”
Although SpineX is still a relatively young company, both SCONE and SCiP have received a breakthrough device designation by the FDA, which is the agency’s way of identifying and prioritizing new technology that saves lives and treats debilitating diseases. SCONE is currently in multicenter clinical trials, and SCiP is on the horizon to start clinical enrollment in early 2024. Parag proudly reports that for SCONE alone, between 30 and 35 patients have seen significant improvements in their bladder function. Similarly, SCiP has improved the quality of life of about 46 children with cerebral palsy.
With his company headed towards a bright future, Parag is quite excited about the new frontiers in the bioelectric space. “Be it invasive, non-invasive, optogenetic…the applications are infinite. From migraine treatment to spasticity treatment to parenteral dysfunction to pain — pretty much everything can be managed with bioelectrical medicine.”
Key Learnings From Parag’s Experience
- Moving from academia to entrepreneurship brings a whole new set of challenges. Be prepared for a steep learning curve as you navigate the various operational, financial, and technological hurdles. Surround yourself with experienced and passionate people and commit to clinical evidence to inform your decision-making. Most importantly, never stop learning.
- Building credibility is crucial for long-term success. For SpineX, FDA's Breakthrough Device Designation for its flagship products has certainly helped. Explore possible routes to demonstrating trust and remember that establishing legitimacy early on can have a lasting impact on your company's success.
- There are viable alternatives to venture capital for securing funds for your startup, such as grants, for example. While submitting them can be meticulous and time-consuming, it’s not impossible to master. Illustrate both the social impact and commercial viability of your product to raise the odds for securing this type of non-dilutive capital.
After 12 years at UCLA, Parag Gad founded SpineX to turn cutting-edge science into life-changing devices. The FDA has granted Breakthrough Device Designation for two of SpineX's non-invasive products aimed at improving the lives of adults with neurogenic bladder conditions and children with cerebral palsy. The company has raised $3.6 million in equity financing and has also secured non-dilutive funding from various government agencies. With ongoing multicenter clinical trials and plans for future enrollment, Parag is steering SpineX toward a new frontier in bioelectric medicine.
Transitioning From Academia to Entrepreneurship
Parag’s motivation to shift from academia to entrepreneurship was that he discovered a technology goldmine that actually benefits people in significant ways. “Limiting it to a lab environment where we could treat 5, 10 individuals a year didn't seem right,” says Parag.
However, transitioning from academia — or any other field — to entrepreneurship comes with its unique set of challenges, as Parag notes. For instance, bringing a product to market is significantly more complex than publishing a paper. It demands diverse skills, from R&D to fundraising. While learnings from academia or other fields can be adaptable, the key to success is acknowledging your limitations and seeking expertise to fill those gaps.
Another great way to break down the challenges of bringing a product to the market is to think about the minimum viable product (MVP) in the context of your startup. Referring to Peter Thiel’s book Zero to One, Parag advises budding entrepreneurs to ask themselves, “What is the MVP, what do I need to do to get to a product that I know will work?”
Then, you can start thinking about capital efficiency, resource allocation, and engaging with potential investors. “We probably would laugh at ourselves as to what we put together for our initial alpha device, but it worked. It did the job. That one key approach (creating an MVP) was critical for us to begin tackling this problem,” Parag says.
Launching a startup, particularly in a specialized sector like medtech, the right team is critical. Parag highlights how his cofounder, Dr. Evgeniy Kreydin, a urologist, brought invaluable medical expertise to the table, particularly during interactions with regulatory bodies like FDA.
This expertise, coupled with a team that shares your vision and work ethic, can be a differentiated factor for a startup. Parag points out that entrepreneurship demands an unconventional level of dedication, adaptability, and willingness to tackle challenges head-on. This is especially vital for early-stage ventures and hybrid teams consisting of full-time employees and consultants. His straightforward advice to entrepreneurs is clear: Your team is your most significant asset in overcoming development and regulatory hurdles, so choose wisely.
Lastly, one of the pillars upon which you should build your venture is empirical data. Parag underscores the value of grounding business decisions in solid clinical evidence, peer-reviewed publications, and expert opinions. This not only enhances your credibility but also sets your venture on a course for sustainable market traction. By basing choices on reliable evidence, you mitigate the risk of biased decisions.
Credibility as a Long-Term Asset
SpinX is set up to be a long-term, global player in the market thanks to Parag’s ambition to get things right from the start. Their two flagship devices received Breakthrough Device Designation from FDA, which means the review process will be prioritized by the agency. In addition, an achievement like this can catalyze other opportunities and bring a significant amount of credibility to SpineX. “Having the Breakthrough Device Designation goes a long way," Parag says. It puts an “informal stamp of approval” on your venture, which is a paramount win for any startup in the healthcare sector.
In the early stages, every interaction with the FDA counts, whether it's a pre-submission meeting or formal review discussion. The level of professionalism and meticulous attention to detail will set the stage for future engagements. These interactions shape FDA’s confidence and trust in what you bring to the table. In the healthcare space, where patient safety is paramount, this trust is a form of capital that can have long-lasting impacts on a company's success.
Therefore, it’s critical to start off on the right foot. Breakthrough Device Designation is just one avenue for establishing credibility. There are alternative strategies as well, such as winning industry-specific awards, generating robust data through benchmark studies to improve patient care, securing intellectual property rights, and collaborating with well-known healthcare providers.
Taking careful, thoughtful steps in early interactions with regulatory bodies paves the way for smoother sailing down the line and contributes to building a brand in the eyes of crucial stakeholders, even if your company is not yet patient-facing.
Going Beyond Venture Capital
Over the past four and a half years, SpineX has raised $3.6 million in equity. However, what's particularly noteworthy is how the company secured non-dilutive funding, mainly from government agencies like the NIH and NSF.
"With my academic background, I found that I had a knack for grant writing," Parag reflects. The skill, he explains, is worlds apart from negotiating with investors. "You have to understand that grant proposals have their own set of rules and limitations. Unlike discussions with investors, you don't have the opportunity to go back and clarify or amend your proposal. So, it's crucial to get it right the first time," Parag emphasizes. For those new to this area, Parag recommends leveraging platforms that offer grant writing coaching or even engaging specialized consultants.
When it comes to equity-based financing, the success of SpineX in attracting early-stage investors was rooted in a compelling narrative. "We were able to not only show the social impact of our medical devices but also demonstrate their commercial viability," says Parag. They simply laid out that their product is a win for everyone involved.
As SpineX is currently in the midst of a Series A round, Parag reflects on the changing economic landscape and the importance of being "realistic.” It’s natural for founders to harbor a strong bias toward their product, but it's essential to couple that enthusiasm with a pragmatic understanding of market dynamics. You need to adjust your expectations based on what the market can bear.
Some entrepreneurs leave a legacy not only for their inventions but also for the heart they put into their work. Such is the story of Parag Gad, the co-founding CEO of SpineX, which is a clinical-stage bioelectric medtech startup doing more than just pushing boundaries in healthcare. With groundbreaking, non-surgical devices that improve neurological conditions, Parag and his team at SpineX are genuinely improving the quality of life for adults and children struggling with debilitating conditions like spinal cord injuries, stroke, and cerebral palsy.
Despite being formally trained as a biomedical engineer, Parag’s real mastery lies in neurophysiology.
His venture into entrepreneurship came after 12 years of rigorous training in neurophysiology at UCLA. With over 15 years of experience in both preclinical and clinical research and product development, Parag's ambition to transform basic science into life-changing products materialized with the launch of SpineX in 2018.
After laying a foundation steeped in research and development, SpineX is championing two groundbreaking products, SCONE and SCiP, which are both extensions of their same platform technology but solve different problems in different patient groups.
SCONE assists adults suffering from neurogenic bladder while SCiP is designed to serve children struggling with cerebral palsy by improving their sensory-motor functions. Both devices leverage the power of spinal neuromodulation to improve patients’ life quality. What separates these from other interventions in this space is their non-invasive, non-surgical, and thus painless nature, and their ability to induce long-term neuroplasticity.
As Parag explains, “You wear it for an hour a day, a couple of times a week, and you're able to induce what's called neuroplasticity in the brain and spinal cord. So the improved function that you're observing is not only present when the electrical neuromodulation is actively delivered, but you're actually causing changes in the organization of the brain and spinal cord, allowing them to retain function even in the absence of active stimulation.”
Although SpineX is still a relatively young company, both SCONE and SCiP have received a breakthrough device designation by the FDA, which is the agency’s way of identifying and prioritizing new technology that saves lives and treats debilitating diseases. SCONE is currently in multicenter clinical trials, and SCiP is on the horizon to start clinical enrollment in early 2024. Parag proudly reports that for SCONE alone, between 30 and 35 patients have seen significant improvements in their bladder function. Similarly, SCiP has improved the quality of life of about 46 children with cerebral palsy.
With his company headed towards a bright future, Parag is quite excited about the new frontiers in the bioelectric space. “Be it invasive, non-invasive, optogenetic…the applications are infinite. From migraine treatment to spasticity treatment to parenteral dysfunction to pain — pretty much everything can be managed with bioelectrical medicine.”
Key Learnings From Parag’s Experience
- Moving from academia to entrepreneurship brings a whole new set of challenges. Be prepared for a steep learning curve as you navigate the various operational, financial, and technological hurdles. Surround yourself with experienced and passionate people and commit to clinical evidence to inform your decision-making. Most importantly, never stop learning.
- Building credibility is crucial for long-term success. For SpineX, FDA's Breakthrough Device Designation for its flagship products has certainly helped. Explore possible routes to demonstrating trust and remember that establishing legitimacy early on can have a lasting impact on your company's success.
- There are viable alternatives to venture capital for securing funds for your startup, such as grants, for example. While submitting them can be meticulous and time-consuming, it’s not impossible to master. Illustrate both the social impact and commercial viability of your product to raise the odds for securing this type of non-dilutive capital.
After 12 years at UCLA, Parag Gad founded SpineX to turn cutting-edge science into life-changing devices. The FDA has granted Breakthrough Device Designation for two of SpineX's non-invasive products aimed at improving the lives of adults with neurogenic bladder conditions and children with cerebral palsy. The company has raised $3.6 million in equity financing and has also secured non-dilutive funding from various government agencies. With ongoing multicenter clinical trials and plans for future enrollment, Parag is steering SpineX toward a new frontier in bioelectric medicine.
Transitioning From Academia to Entrepreneurship
Parag’s motivation to shift from academia to entrepreneurship was that he discovered a technology goldmine that actually benefits people in significant ways. “Limiting it to a lab environment where we could treat 5, 10 individuals a year didn't seem right,” says Parag.
However, transitioning from academia — or any other field — to entrepreneurship comes with its unique set of challenges, as Parag notes. For instance, bringing a product to market is significantly more complex than publishing a paper. It demands diverse skills, from R&D to fundraising. While learnings from academia or other fields can be adaptable, the key to success is acknowledging your limitations and seeking expertise to fill those gaps.
Another great way to break down the challenges of bringing a product to the market is to think about the minimum viable product (MVP) in the context of your startup. Referring to Peter Thiel’s book Zero to One, Parag advises budding entrepreneurs to ask themselves, “What is the MVP, what do I need to do to get to a product that I know will work?”
Then, you can start thinking about capital efficiency, resource allocation, and engaging with potential investors. “We probably would laugh at ourselves as to what we put together for our initial alpha device, but it worked. It did the job. That one key approach (creating an MVP) was critical for us to begin tackling this problem,” Parag says.
Launching a startup, particularly in a specialized sector like medtech, the right team is critical. Parag highlights how his cofounder, Dr. Evgeniy Kreydin, a urologist, brought invaluable medical expertise to the table, particularly during interactions with regulatory bodies like FDA.
This expertise, coupled with a team that shares your vision and work ethic, can be a differentiated factor for a startup. Parag points out that entrepreneurship demands an unconventional level of dedication, adaptability, and willingness to tackle challenges head-on. This is especially vital for early-stage ventures and hybrid teams consisting of full-time employees and consultants. His straightforward advice to entrepreneurs is clear: Your team is your most significant asset in overcoming development and regulatory hurdles, so choose wisely.
Lastly, one of the pillars upon which you should build your venture is empirical data. Parag underscores the value of grounding business decisions in solid clinical evidence, peer-reviewed publications, and expert opinions. This not only enhances your credibility but also sets your venture on a course for sustainable market traction. By basing choices on reliable evidence, you mitigate the risk of biased decisions.
Credibility as a Long-Term Asset
SpinX is set up to be a long-term, global player in the market thanks to Parag’s ambition to get things right from the start. Their two flagship devices received Breakthrough Device Designation from FDA, which means the review process will be prioritized by the agency. In addition, an achievement like this can catalyze other opportunities and bring a significant amount of credibility to SpineX. “Having the Breakthrough Device Designation goes a long way," Parag says. It puts an “informal stamp of approval” on your venture, which is a paramount win for any startup in the healthcare sector.
In the early stages, every interaction with the FDA counts, whether it's a pre-submission meeting or formal review discussion. The level of professionalism and meticulous attention to detail will set the stage for future engagements. These interactions shape FDA’s confidence and trust in what you bring to the table. In the healthcare space, where patient safety is paramount, this trust is a form of capital that can have long-lasting impacts on a company's success.
Therefore, it’s critical to start off on the right foot. Breakthrough Device Designation is just one avenue for establishing credibility. There are alternative strategies as well, such as winning industry-specific awards, generating robust data through benchmark studies to improve patient care, securing intellectual property rights, and collaborating with well-known healthcare providers.
Taking careful, thoughtful steps in early interactions with regulatory bodies paves the way for smoother sailing down the line and contributes to building a brand in the eyes of crucial stakeholders, even if your company is not yet patient-facing.
Going Beyond Venture Capital
Over the past four and a half years, SpineX has raised $3.6 million in equity. However, what's particularly noteworthy is how the company secured non-dilutive funding, mainly from government agencies like the NIH and NSF.
"With my academic background, I found that I had a knack for grant writing," Parag reflects. The skill, he explains, is worlds apart from negotiating with investors. "You have to understand that grant proposals have their own set of rules and limitations. Unlike discussions with investors, you don't have the opportunity to go back and clarify or amend your proposal. So, it's crucial to get it right the first time," Parag emphasizes. For those new to this area, Parag recommends leveraging platforms that offer grant writing coaching or even engaging specialized consultants.
When it comes to equity-based financing, the success of SpineX in attracting early-stage investors was rooted in a compelling narrative. "We were able to not only show the social impact of our medical devices but also demonstrate their commercial viability," says Parag. They simply laid out that their product is a win for everyone involved.
As SpineX is currently in the midst of a Series A round, Parag reflects on the changing economic landscape and the importance of being "realistic.” It’s natural for founders to harbor a strong bias toward their product, but it's essential to couple that enthusiasm with a pragmatic understanding of market dynamics. You need to adjust your expectations based on what the market can bear.
