Category Archive For "Startup Spotlight"
Diavacs is a preclinical biotechnology company developing first-in-class therapies to prevent and reverse the onset of autoimmune disease. Their initial focus is reversing new-onset type 1 diabetes (an orphan indication).
We got in touch with Head of Operations Mr. Richard Murphey to discuss Diavacs’s approach.
What motivates your company?
Our CEO, Alan Lewis, was previously the CEO of the Juvenile Diabetes Research Foundation, the leading non-profit funder of type 1 diabetes research in the country. In that role, he has met hundreds of people and families living with type 1. For these people, insulin therapy keeps their life-threatening disease at bay, but managing the disease requires constant vigilance: one off day can mean a hospital visit (or worse).
A lot of people don’t realize how big the unmet need is in type 1, but even with great self-management, insulin does not necessarily prevent the serious complications of type 1, including blindness, leg amputations, and kidney failure. We think that giving patients a chance to avoid these complications is a goal worth working towards.
What has been the biggest achievement you accomplished?
Our biggest achievement has been pushing our technology to its limits and uncovering the broad potential of our platform beyond type 1. When we licensed our product from Baxter and the University of Pittsburgh, it was able to prevent and reverse type 1 diabetes in animal models by inhibiting the expression of three proteins by 40-50 percent.
We have since optimized the product to consistently achieve 95%+ inhibition of these same proteins. This could mean longer-lasting effectiveness, less dependence on insulin, and a better chance at preventing downstream complications like foot amputations or kidney transplants. It could also mean our platform can be used to treat other autoimmune diseases like rheumatoid arthritis or Crohn’s disease, or even cancer.
How does your therapy treat type 1 diabetes?
At the heart of the vicious cycle of autoimmunity are dendritic cells. Dendritic cells collect antigens from destroyed beta cells and present these antigens to T cells, programming these T cells to destroy beta cells. Diavacs’ technology re-engineers dendritic cells by using antisense-DNA to inhibit the expression of three key molecules (CD40, CD80 and CD86) involved in programming cytotoxic T cells to attack beta cells. These re-engineered dendritic cells protect healthy tissue by stimulating a type of tolerogenic T cell called a “T regulatory” cell and also by destroying cytotoxic T cells.
If patients are treated with this approach within a few months of being diagnosed, we believe we can stop the autoimmune attack in its tracks while the body is still able to produce sufficient insulin, effectively reversing the onset of Type 1 Diabetes. Further, recent evidence suggests that beta cells regenerate throughout a patient’s life, and by protecting these new beta cells, we hope that Diavacs’ products can restore full function to patients.
Our approach has successfully reversed the onset of Type 1 Diabetes in animal models of disease. While Diavacs will not initiate its first study in humans until 2018, other therapies designed to create more T regulatory cells have been successful in treating autoimmune diseases in humans. We believe our approach may have a better safety profile, be more convenient for patients, and be potentially more effective than other approaches
Tell us about upcoming projects or events your company will have.
The most exciting near-term milestone is initiation of our first animal study of Type 1 Diabetes with our optimized formulation. We are kicking this off as we speak and expect this study to read out in late 2017. Completion of this study will enable us to meet with the FDA to discuss when we are able to initiate our first human study. Our partners did a ton of great work on the product before we licensed it, and FDA is familiar with a lot of this work, so we hope this will mean a quick path into clinical trials. A positive proof of concept study in humans will be a tremendous accomplishment for the company, a meaningful value inflection point for investors, and an incredibly promising development for patients.
In addition to the Type 1 work, we are looking to use our platform to develop additional candidates to treat other autoimmune diseases and cancer. One project we are particularly excited about is using our product to program dendritic cells to activate T cells against neoantigens in cancer. We are in discussions with some academic researchers about applying for grants to fund this work, but if we get some additional equity funding we can get started sooner.
What is your company’s ultimate goal?
Our ultimate goal is to help people with autoimmune disease to live happier and healthier lives. There are a lot of great products out there that relieve symptoms for some of these people, but most of these products come with their own baggage, and very few medicines exist to alter the course of these diseases in a sustainable way. Hopefully we can offer a product to patients that significantly reduces the burden of their illness.
How does your company stand out from the competition?
Most drugs for autoimmune disease are broad-acting anti-inflammatory products that treat autoimmunity but also weaken the immune system’s ability to fight other infections. Our product is designed to induce local, rather than systemic, immune tolerance: we reduce immunogenic activity in the parts of the body where the immune system is malfunctioning, but we do not broadly reduce the immune system’s ability to fight infections.
To our knowledge, we are the only company developing therapies that act locally versus systemically. However, there are several companies that are trying to limit systemic side effects through other means, often through antigen-specific approaches. Some of the most promising products for not just type 1 but autoimmunity in general act by expanding populations of T regulatory cells that stop autoimmunity — analogous to the most promising new cancer therapies that act by expanding populations of T cells that fight tumors. Notable examples of this approach include Delinia (acquired by Celgene in January), Parvus (recently partnered with Novartis) and Caladrius (public).
Our product also expands populations of T regulatory cells, but we believe our product has two other mechanisms of action that competitors do not: reduction in populations of T effector cells and expansion of B regulatory cell populations. In type 1 diabetes, there is a big difference between, say, reducing required insulin injections by 25 percent and reducing dependence on insulin entirely. We hope that our product’s additional mechanisms of treating the autoimmune pathology will put us closer to the latter goal.
All that said, the field of autoimmunity is vast and there is room for several next-generation products. As one of the largest therapeutic areas, we believe pharmaceutical companies will look to bolster their pipelines with several promising candidates, and we have spoken with several large biopharma companies that are excited about our approach.
The mechanical thrombectomy market is ready for a new technology to replace outdated methods. Devices currently in the market have been used for over a decade and fall short as they are prone to distal embolization, inefficient aspiration, and clogging.
Capture Vascular has developed and commercialized the MegaVac Mechanical Thrombectomy System (MegaVac System), a technology uniquely designed to remove thrombus and emboli throughout the peripheral and coronary vasculature. This innovative technology offers occlusion, centering, anchoring, removal of clot, and delivery of fluids in one simple, efficient, and effective device.
angelMD had a chance to talk to Capture Vascular’s CEO, Eric Wells, and learn more about
their important work. If you’d like to know more about this exciting AngelMD company, please click on this link to be included in exclusive Communications.
How does the MegaVac Mechanical Thrombectomy System work?
The MegaVac System utilizes two components:
1. A novel vessel occluding funnel catheter (MegaVac catheter) which provides a large funnel mouth to receive the clot.
2. A wire based expandable clot retractor (ThromboWire) to retract the clot to the large mouth funnel of the MegaVac and to pull the clot into and through the shaft of the catheter while aspiration is being provided to the MegaVac.
The funnel of the MegaVac occludes blood flow with the patient’s own blood pressure using SafeSeal Technology to create a static environment which inhibits distal migration of thrombus, embolus, and other debris, and at the same time centering and anchoring the catheter. This method of two components working synchronously and in concert can be easily understood by viewing the video at www.capturevascular.com.
Why is it important to ensure complete clot removal?
In general, complete clot removal does a few things:
1. Eliminates the acute obstruction.
2. Minimizes or prevents distal embolization of residual thrombus that may occur at a later date or with subsequent treatment to the area (angioplasty, stenting, etc.).
3. Minimizes the subsequent formation of new thrombus on residual thrombus,
4. Provides for optimal stent apposition to the wall of the vessel vs. sandwiching residual thrombus between the stent and arterial wall which can be problematic subsequently.
5. Essentially restores the vessel to the condition prior to the thrombotic event.
What effect does your system have on non-thrombus arterial obstruction, like arterial calcifications?
The MegaVac catheter anchors and centers the distal catheter just proximal to an occlusion which more easily allows antegrade passage of crossing wires and other devices through the occlusion. Moreover, once the occlusion is navigated, therapeutic devices (atherectomy, drug coated balloons, etc) to treat the non-thrombotic occlusion may be passed through the MegaVac and utilized in a static environment that inhibits the distal migration of the liberated debris preventing distal arterial occlusion in the runoff vessels. Essentially, the MegaVac System allows the non-thrombotic occlusion to be navigated more easily and treated more safely.
What advantages does the MegaVac Mechanical Thrombectomy System offer over its competitors?
In thrombus removal, the MegaVac System provides several advantages:
- Vessel occlusion that minimizes or prevents distal embolization during the procedure.
- Anchoring of the distal MegaVac catheter that allows the operator to cross tight stenoses or tortuous vessel segments more easily.
- A large mouth funnel to receive the thrombus burden.
- The ThromboWire clot retractor to pull the thrombus into the large mouth funnel, to remove wall adherent clot, and to prevent catheter clogging by retracting the clot through the entire length of the catheter and into the aspiration syringe.
In non-thrombotic arterial occlusion, the MegaVac System provides a static work environment by occluding the vessel and minimizing distal migration of debris. It centers the distal catheter for more efficient antegrade passage of wires and tools, and anchors the distal catheter for more push ability of wires and tools. This allows the passage and utilization of therapeutic devices to treat the lesion while maintaining the proximal occlusion, and provides for the aspiration of any debris from the treatment prior to restoring flow.
Are the tools for removal of coronary artery thrombus different than the ones for peripheral artery thrombus?
Yes. Usually coronary artery thrombus is acute and rather soft. Most of this may be simply aspirated by the MegaVac. However, there may be a wall adherent clot that may not be removed by simple aspiration. Use of the ThromboWire removes this wall adherent clot that may prevent proper stent apposition to the arterial wall if not removed prospectively. Improper stent apposition has been implicated in in-stent restenosis, late stent thrombosis, and diminished outcomes amongst other untoward effects.
Moreover, minimizing distal embolization may be more important in the coronary arteries than in the peripheral vasculature. Distal embolization, when present, was associated with a 3X mortality in a subset analysis of the TOTAL Trial despite there being no difference in overall mortality with simple aspiration thrombectomy vs. no thrombectomy. With standard thrombectomy devices, distal embolization frequently occurs once flow has been restored. The MegaVac provides proximal occlusion during the entire thrombectomy procedure with aspiration of thrombus and debris to inhibit the distal embolization that may be very important to patient outcomes.
How have the TASTE and TOTAL Trials affected coronary thrombectomy and where does the MegaVac fit into that picture?
Both trials compared survival outcomes of performing routine thrombectomy with simple straw like aspiration catheters vs. no thrombectomy on all comers regardless if there was significant thrombus or not prior to angioplasty/stenting of patients presenting with STEMI. There was no survival difference between the two groups.
While the trials have been criticized on a number of fronts, the lack of any difference in mortality has caused a significant decrease in thrombectomy in STEMI cases. This expected reaction has bottomed and the use of thrombectomy in STEMI is now growing again, albeit the market is still smaller than prior to these studies.
Expanding on the answer in question 5, standard simple aspiration thrombectomy catheters, like those used in these two trials, frequently do not remove the majority of the clot. Once any flow is restored, most of the residual clot is simply washed off the wall and propelled downstream before it can be removed. Hence, the devices used in these two studies may be at least partially, if not mostly, responsible for the lack of differences between the two groups.
Because the MegaVac occludes flow prior to any aspiration, the aspiration efficiency is dramatically improved and thrombus and debris are not propelled downstream. Moreover, the ThromboWire may be used to remove wall adherent clots which, when present, prevent optimal stent apposition and may cause the resultant complications listed previously. Simply put, the MegaVac has the potential to remove more thrombus easier and more completely than current devices while preventing downstream embolization.
What interest in Capture Vascular have you had from physicians and industry?
Uniformly very positive. Physicians and KOL’s see the need for the device, understand the simple, intuitive concepts, perceive the potential benefits, and readily embrace the advances the MegaVac System offers. Many are eager to utilize it in their practice. Industry representatives also recognize the above positive benefits. They, understandably, wish to see market adoption before further substantive conversations.
How do you think syndicating an investment with angelMD will benefit Capture Vascular?
In addition to providing capital to pursue commercialization and the necessary market adoption that will further spur industry interest, syndicating with angelMD may provide a network of valuable resources to supply clinical feedback, perspectives, and information for the current intended and other not yet contemplated uses of the MegaVac System.
Tell us about your team and their unique capability in this specific field?
Capture Vascular has contracted with Telluride Medical Partners, (TMP) to provide management, development, marketing, accounting and other essential services necessary for an eventual successful exit. The TMP offer decades of experience in the development and commercialization of medical products. In addition to the TMP team, TMP has an advisory board with a vast knowledge of products, device commercialization, and M&A.
What is your current status on key company goals for the next 12 months?
Below is a sample of a few of Capture Vascular’s key initiatives for 2017:
- PAD product to market and expand adoption with strategic industry partners
and high volume offices.
- Design Freeze CAD devise and introduce 100 devices to market by Q-4 2017.
- Complete development of DVT device and conclude in vitro and in vivo testing.
- Issuance of CE mark for PAD device.
We are moving along per our plan on all three of these key initiatives:
- The PAD product is in the market.
- CE audit was done last month and issuance will be Aug 2017
- CAD prototypes were used in animal last week and the design functioned very well.
- Early stage DVT device was tested last week in lab and the results were positive allowing us to advance to a complete prototype.
Perinatal hypoxic-ischemic encephalopathy (HIE), caused by oxygen deprivation to the brain, occurs in one to nine of every 1000 live births, and can lead to neurodevelopment disorders ranging from mild behavioral deficits to seizure disorders and cerebral palsy1,2. Additionally, an estimated 23% of the 4 million worldwide annual neonatal deaths are associated with signs of asphyxia during birth1; however current electronic fetal monitoring systems have limitations and their impact on neonatal outcomes is controversial3,4.
Noninvasix Inc., a Texas-based medical device startup, has developed patented optoacoustic technology to directly measure neonatal and fetal oxygenation levels to try to improve neonatal outcomes. Noninvasix’s technology relies on the thermo-elastic response of hemoglobin to certain wavelengths of near-infrared (NIR) radiation. NIR radiation ranging from 680-2400 nm with pulse durations of approximately 10 ns can be pulsed through the scalp and skull into the superior sagittal sinus (SSS), a large cerebral vein. Oxygenated and deoxygenated hemoglobin responds differently to pulsed NIR radiation. For example, at 1064 nm, hemoglobin absorption increases with oxygenation, while at 700 nm it decreases with oxygenation. The absorption of NIR radiation results in a measureable optoacoustic wave with distinct pressure profiles between oxygenated and deoxygenated hemoglobin and is detected with a piezoelectric transducer5.
Noninvasix’s clinical prototype has been tested in both fetuses and neonates at The University of Texas Medical Branch at Galveston, and has also demonstrated results in large animal studies.
Noninvasix’s technology differs from the current noninvasive oxygenation measurement standard, NIR spectroscopy (NIRS), in that it detects an acoustic wave rather than a light wave. Noninvasix’s optoacoustic technology has a higher spatial resolution than NIRS measurements, as acoustic waves scatter less in tissues than light waves do6. As a result, Noninvasix’s optoacoustic technique can measure venous blood oxygenation alone rather than measuring a mixed blood saturation of venous, capillary, and arterial blood5,7.
Dr. Rinat Esenaliev, Ph.D., Noninvasix Vice President for R&D, and Dr. Donald Prough, M.D., Clinical Vice President are co-inventors of the technology. In 2012, they, along with a team of researchers, demonstrated that their optoacoustic device and the gold standard invasive device, a CO-oximeter, resulted in similar oxygenation measurements. The optoacoustic-predicted oxygenation levels and the CO-oximetry oxygenation levels had a correlation coefficient, R2, equal to 0.931. This study was conducted using NIR radiation of 700, 805, and 1064 nm in adult merino sheep, which have a scalp and skull thickness comparable to humans, but a SSS that is approximately five times smaller than that of humans. The 700 and 1064 nm wavelengths resulted in oxygenation-dependent absorption profiles, while the 805 nm wavelength acted as a reference signal as hemoglobin absorption is not dependent on oxygenation at this wavelength5.
Noninvasix’ technology may also be applied to other medical needs including intracranial hematoma diagnosis and the treatment of traumatic brain injury which can cause hematomas 6. In a 2014 study, Dr. Esenaliev and other researchers identified blast-induced intracranial and extracranial hematomas in rats based on the time course of the optoacoustic signal8, and Noninvasix is still developing other applications for their platform technology.
- Eghbalian, F. Frequency of Hypoxic-Ischemic Encephalopathy among Hospitalized Neonates in West Iran. Iran. J. Pediatr. (2010).
- Lai, M.-C. & Yang, S.-N. Perinatal hypoxic-ischemic encephalopathy. J. Biomed. Biotechnol. (2011). http://www.ncbi.nlm.nih.gov/pubmed/21197402
- Sartwelle, T. P. & Johnston, J. C. Cerebral palsy litigation: change course or abandon ship. J. Child Neurol. (2015).
- Clark, S. L. et al. The limits of electronic fetal heart rate monitoring in the prevention of neonatal metabolic acidemia. Am. J. Obstet. Gynecol. (2017).
- Petrov, I. Y. et al. Optoacoustic monitoring of cerebral venous blood oxygenation though intact scalp in large animals. Opt. Express (2012).
- Esenaliev, R. O. Optoacoustic diagnostic modality: from idea to clinical studies with highly compact laser diode-based systems. J. Biomed. Opt. (2017).
- Pellicer, A. & Bravo, M. del C. Near-infrared spectroscopy: A methodology-focused review. Semin. Fetal Neonatal Med. (2011).
- Petrov, A. et al. Optoacoustic detection of intra- and extracranial hematomas in rats after blast injury. Photoacoustics (2014).
This week’s #StartupSpotlight is AxoSim, a company dedicated to bringing their “Nerve-on-a-Chip” to market.
AxoSim was founded to address a problem in the pharmaceutical industry: 89 percent of new drugs fail in clinical trials, largely due to the limitations of animal testing to predict human results. As a result, a single successful drug costs an average of $80 million and takes up to 15 years to reach the market.
The Nerve-on-a-Chip is a more accurate, less expensive, and faster alternative to animal testing, delivering results in weeks versus months and at a fraction of the $100s of thousands spent on animal testing for each potential version of a drug. Looking longer term, the ability to increase clinical success rates represents the greatest value. Even moving the needle by single digits from the current 89% clinical failure rate would mean savings of $100s of millions due to wasted resources.
After several key discussions with pharma executives, the founding inventors recognized the market need for better alternatives to animal testing, particularly in the neurodegenerative disease space. AxoSim spun out of Tulane University in 2014 to solve this problem by improving clinical prediction and saving pharmaceutical companies hundreds of millions of dollars and years of wasted patent life.
The patent-pending Nerve-on-a-Chip platform uses living human neural cells engineered in a 3D environment to reproduce the environment of a nerve. This allows AxoSim to predict changes to the human functionality and structure based on drug exposure.
AxoSim’s CEO, Lowry Curley, originally worked on the proprietary Nerve-on-a-Chip during his PhD in biomedical engineering at Tulane University with his advisor and eventual co-founder Michael J. Moore, PhD. After working in several senior product development positions, including an international consortium involving Janssen Pharmaceuticals, Lowry returned to partner with Michael and found AxoSim.
Michael serves as Chief Science Officer (CS) and originally studied with the world’s most renowned translational researcher, Dr. Robert Langer at MIT. There he cultivated a drive towards translational research and a deep understanding of spinning out university incubated technology. In addition, his tenured position at Tulane serves as a de-facto R&D arm for the company.
Ben Cappiello joined AxoSim as a seasoned biotech entrepreneur. His past experiences include raising over $4 million to successfully obtain FDA clearance for a women’s health medical device.
Since its founding in 2014, AxoSim has received $750,000 in non-dilutive funding, which spurred growth from two employees to the current team of seven. AxoSim obtained the exclusive world-wide license for its core technology platform and has already filed an additional provisional patent through Tulane University. 2016 was spent developing two additional applications for the platform: ALS and MS.
AxoSim’s hard work is beginning to pay off with $250,000 in revenue already booked for 2017.
AxoSim is working to grow its internal resources, team, and facilities. Fundraising efforts are focused primarily on scaling infrastructure and increasing marketing efforts.
For this week’s #StartupSpotlight, we take a look at Medifies, a company building a platform that helps healthcare providers give updates to families while maintaining HIPAA compliance. We spoke with CEO Nate Pagel, to learn about Medifies. To find out more about Medifies, check out their angelMD profile.
Please provide a short overview of your company and the market need you are fulfilling.
Medifies delivers the most innovative SaaS platform for healthcare provider-to-family and caregiver notifications. Every day in America, 200,000 people anxiously fret in OR waiting rooms for loved ones in surgery without knowing what is going on or when to expect updates. We solve this problem.
Historically, healthcare has focused on doctor-to-patient communication; Medifies revolutionizes healthcare with staff-to-caregiver/family notifications. The company allows non-clinical staff to deliver templated notifications to the phones of a patient’s family and caregivers. In addition, it saves clinicians time, providers money, and connects providers with the entire family for the first time—for future patient acquisition.
Medifies addresses problems that all healthcare providers face with a scalable platform which also improves the experiences of families in need of reassurance at a difficult time.
Why did you start your company?
I was approached by my high school friend, Dr. John Talieh, who is a CT surgeon and Chief of Surgery at Sutter Memorial. Dr. Talieh wanted to solve problems he sees around surgery every day:
- Families are stressed and feel tethered to the waiting room, but they also are often not present during the important time after surgery when the surgeon needs to speak with them.
- Incorrect or embellished updates can result in malpractice claims.
Medifies solves these problems and many more for providers, like increasing HCAHPS and Press Ganey scores, in addition to increasing the satisfaction of family members with a superior experience and templated updates, like “The surgeon will come speak with you in the waiting room soon.”
What were some of the biggest hurdles you had to overcome in getting your company off the ground?
The biggest hurdle was long provider sale cycles. We are addressing that by taking a strategic approach to selling within IDNs as well as approaching surgicenters with a flatter hierarchy and quicker ability to make decisions.
Is there a specific culture you strive to create at your organization?
Our motto is “We are family.” This reflects not only the population we serve but also the culture we cultivate. We take care of each other as a team, and all of us feel strongly that we have a great product which we want to succeed. We work hard in a field with tough turns, so it’s also important to have fun.
How are you trying to differentiate yourself from your competitors?
Currently, there is no uniform method of communicating with patients’ families. There are a few hospitals that have costly and hard-to-understand waiting room monitors. In contrast, Medifies requires no installation, no IT investment, no downtime, and no data loss. By not revealing PHI or PII the service is HIPAA compliant while delivering relevant information.
Where do you see the biggest potential for growth in your industry?
Patient (and caregiver) experience. It is currently the #1-funded sector and also the top area of M&A activity in all of healthcare. Our biggest potential for growth is taking advantage of the wide-open provider-to-family notification space.
Our initial product is designed for families of patients undergoing surgery, but there are numerous other procedures (like radiology) and arenas of care (like elder care, dementia care, and hospice) that will tremendously benefit from caregiver communication. The Medifies platform is expanding strategically to include caregiver notifications for dialysis, chemotherapy, obstetrics, radiology, elder care, and hospice. These days, you can track everything from your bank accounts to your grocery deliveries on your phone, but you can’t track your loved ones in medical care. We are excited to change that.
Over the past 10 years what has been the biggest technological innovation that has shaped your industry, and has this innovation impacted your business directly?
If we look at technology, there is no question that the answer is the iPhone. Everyone now has a supercomputer with media, location and communication capabilities in their pocket, and the healthcare industry as a whole has yet to take advantage of it. Our thesis is that industry needs to leverage this fact to make lives better. Our CEO’s last four startups have done just that; they’ve been “mobile-first” (designed first for the handheld device) because that is what people predominantly use these days for updates, notifications, etc. One of these, Flyby, was acquired by Apple in Dec 2015.
What is your vision and of the strategy for your company for the future?
Our initial product deals with the OR waiting room, but moving forward, we are branching out into many other areas including the entire perioperative cycle (pre-clinic through readmission), dialysis, chemotherapy, radiology, OB, elder care and hospice. Our goal is to maintain our focus on the largest population in health—the family—while expanding our brand and suite of products so that patients choose their healthcare provider based on who uses Medifies. Once you’ve had Medifies on your phone, how could you go without it again?
What should I have asked you that I didn’t?
We like to talk about our experienced team of ten—we have a cumulative 110 years in the healthcare industry! Our CTO is the chair of the HL7 Committee for Mobile Health, and I’ve been lucky enough to have been part of great teams and startups with four exits totaling more than $1.4B.