Category Archive For "angelMD News"
angelMD is pleased to announce that we are opening a syndicate for investment in Otomagnetics, a startup developing an innovative, non-invasive magnetic delivery system for drugs and other therapeutic payloads. If you’re interested in learning more about Otomagnetics, please visit our info form to request more information.
Otomagnetics is a spin-out startup from the University of Maryland at College Park. Their team has developed a magnetic field-generating small device that works with proprietary nano-particle formulation to carry drugs, proteins, or genes. The effect of the localized magnetic field on the nano-particles allows therapeutics to be carried across tissue barriers, and allows delivery to hard-to-reach targets in the body that would otherwise require needles or surgery.
angelMD had a chance to talk to Otomagnetics’ CEO, Dr. Benjamin Shapiro, and learn more about their important work. We hope you enjoy this conversation. If you would like to know more about this innovative angelMD company, please click on this link to be included in exclusive communications.
1. How did you develop the idea to use magnets and magnetized particles as a drug delivery platform?
We got a phone call from an otolaryngology group that was interested in effective but non-invasive drug delivery to the cochlea. This group had found us based on our work in magnetic drug delivery. They were envisioning a large and complex magnetic instrument that would pull particles into the cochlea from the opposite side of the head. Instead, we were able to design a device that pushed (injected) instead of pulled, which allowed the device to be small, simple, and effective. The device was patented, built, and tested first in the lab, and then in animals (and now also in human cadavers). Hence we started as an ear company to fill an unmet drug delivery need.
The same novel magnetic push concept (till then, all other magnetic delivery systems could only pull) has also shown it can deliver therapy into the eye and through the skin, without needles. The system is therefore now also being developed for vision and dermatology.
2. Do you consider Otomagnetics a device or pharma company?
We consider Otomagnetics a biotech company. We have a platform technology. Our delivery system acts like a syringe, but the needle has been replaced by magnetic forces acting on bio-compatible nano-particles that can carry drugs, proteins, or gene therapy. We can reach targets that cannot be reached by current standards-of-care, or that would otherwise require an invasive surgery to reach.
3. Your first target customer is prevention and treatment of sudden hearing loss. How does your approach improve on current therapies?
Current administration methods do not effectively reach the cochlea, and therefore do not treat sudden hearing loss effectively. For oral administration, less than 1 out of 10,000,000 drug molecules reach the cochlea; for trans-tympanic administration, the number is less than 1 out of 40,000 [Juhn, 2001; Inamura & Salt, 1992; Bird, 2007].
We deliver therapy 1,000x more efficiently to the cochlea and have shown we can restore hearing, suppress tinnitus, and prevent hearing loss due to chemotherapy regimens in recognized animal models.
4. What other applications are there for your therapeutic delivery system and what advantages will you offer in those markets?
In addition to treating the cochlea, we can magnetically deliver into the middle ear without needles or surgery. In animal studies, we have shown we can clear middle ear infections. (Chronic and recurrent middle ear infections/inflammations are currently treated by surgical insertion of tubes through the ear drum, the most common pediatric surgery in the US.) For macular degeneration and other eye conditions, we can delivery therapy without needle insertions into the eye.
Animal studies have also shown magnetic forces can deliver therapy through the skin, which enables improved drug delivery to burns, wounds, or diabetic ulcers.
Otomagnetics Magnetic Injection Technology
Learn about Otomagnetics' innovative magnetic injection technology.
5. What third-party validation have you received from the scientific community?
The technology was developed in response to a clinical need articulated by otolaryngologists, a need that is well recognized in the field. Clinicians at Johns Hopkins, Children’s National Medical Center, Sunnybrook Health Sciences Center, and the University of Nottingham have reached out to us, and have initiated projects with our group. In England, the Action of Hearing Loss supports and has helped fund our research and efforts.
6. What interest in Otomagnetics have you had from industry?
Angel investors at Keiretsu envision Otomagnetics as a Star Trek technology, a technology of the future. They are currently in the due-diligence phase and we expect them to conclude their process in next few months. Two pharmaceutical companies are already interested in our magnetic delivery because they recognize it could enable them to deliver their therapeutic compounds safely and effectively to new targets, and we are in discussions with additional companies.
7. How do you think syndicating an investment with AngelMD will benefit Otomagnetics?
Our interest in AngelMD is the access to clinical expertise that it will provide. We started as a company that was motivated by a clinical need in otolaryngology (we were not a technological hammer looking for nails, instead we developed the magnetic injection technology to address a pressing and unmet need). Now that the system has also shown utility for delivering therapy magnetically into eyes and through the skin, without needles or surgery, we would welcome the opportunity to collaborate with clinicians to expand our technology to additional applications and clinical needs.
8. Tell us about your team and their unique capability in this specific field?
Dr. Benjamin Shapiro, PhD, CEO is an expert in magnetic drug targeting, nano-therapy, lab-on-chip/microfluidics. He is a Fulbright scholar, the inventor of the magnetic injection technology, and is currently responsible for the operations for Otomagnetics. He has helped raise over $6M in non-dilutive grant funding for the effort thus far.
Mr. Ting Pau Oei, MBA, Chairman of the Board, has extensive operating and investing experience in the healthcare industry. He has been a venture capital partner in both a corporate strategic venture capital firm and in an independent venture capital partnership. He was a Vice President of Johnson & Johnson Development Corporation, J&J’s venture capital arm. He has invested in over 50 life sciences, medical device and healthcare information technology companies and served on the board of over 25 of these portfolio companies.
Ms. Abhita Batra, MS, MBA, Chief Business Officer, is the Founder and Managing Director of Advanced Biopharma Consulting (ABC), a strategic advisory firm that offers business development and commercialization services to life science companies. She is co-owner of Admac Group of Companies, wherein she managed a product portfolio encompassing 150 generics. She is a co-founder and former COO of Navya, a biotechnology company developing and commercializing PHF for destruction of solid tumors. Abhita completed her Global MBA at UCLA Anderson and NUS, and has a Masters in Biotechnology with specialization in Pharmaceutical Sciences from University of Pennsylvania.
We have expert regulatory advisors, including a former FDA Branch Chief and a former Vice President of R&D at AMAG Pharmaceuticals who previously took two iron-oxide (magnetic) nano-particles through FDA regulatory approval and to market for millions of patients.
9. What are your key company goals for the next 12 months?
Complete FDA-mandated large and small animal safety studies to enable entry into human clinical trials.
angelMD is pleased to announce a new syndicate for investment in Otomagnetics. If you are considering joining this exciting angelMD syndicate, please visit this link to request more information.
angelMD is pleased to announce that we are opening a syndicate to raise capital for Access Vascular. After reading the article below by Arun Jagannathan, MD, please click on this link to be included in exclusive communications.
The backbone of non-emergent central venous access, the ubiquitous PICC line (peripherally inserted central catheter) has become an integral patient care tool since its advent in the 1970s. In comparison to other central venous access options such as tunneled chest catheters and ports, the PICC line can be placed relatively inexpensively by an intravenous access nurse with less patient discomfort and lower risk of certain immediate complications such as pneumothorax.
Benefits vs. Complications
However, balancing these benefits are significant potential complications arising from the placement of a long catheter into a small caliber peripheral vein with multi-week indwell time. These complications include thrombosis, commonly of the peripheral vein but not infrequently of the deep central veins (deep vein thrombosis or DVT), sometimes even resulting in clinically significant pulmonary embolism (PE). Resulting catheter dysfunction typically requires secondary interventions to maintain access such as thrombolytic therapy administration or device exchange. Catheter related bloodstream infection is another potential complication which significantly increases morbidity, hospital stay and overall cost of care. These adverse events are considered avoidable and therefore not reimbursed by payors.
As a vascular and interventional radiologist, the clinical sequelae of PICC line dysfunction are well known to me, as it is my service that is tasked with fixing the problems that arise. While a majority of these lines are placed bedside, the number of difficult placements that require MD intervention is increasing at a rapid rate. Contributing to this change are a combination of factors including an older and sicker patient population who have had a multitude of venipunctures and line placements in the past leaving the venous pathways strictured or obstructed with fibrosis. Also, a greater number of patients are living longer with malignancies and other hypercoagulable states and often present with device related acute DVT/PE, requiring systemic anticoagulation and sometimes catheter directed thrombolytic therapy.
Past improvements in device design, such as antithrombotic coatings and additives, are inelegant solutions that merely mask the underlying problem caused by a thrombogenic intravenous foreign body, and, as a result, have only marginally mitigated the complications.
A Better PICC
Access Vascular has developed an advanced bulk hydrophilic biomaterial that is strong, flexible and biocompatible. The material has a high-water content and a neutral surface charge, yet is strong and load-bearing. These features make it the ideal material from which to craft long-term implantable vascular access devices in order to markedly reduce thrombosis, and in turn, almost completely eliminate complications and adverse events seen with current devices. The proprietary biomaterial is not recognized by the body as a foreign material and therefore does not trigger the body’s thrombotic response. Without adherent blood products on the catheter to act as a nidus for infection as well as the inability for microbial biofilm to grow across the hydrophilic surface, the device has the potential to significantly lower infectious complication rates without relying on antimicrobial coatings or additives.
In benchtop biocompatibility studies and short preclinical studies the biomaterial has proven to be antithrombogenic. It has shown up to a 98% reduction in thrombus accumulation in comparison to controls. The company is now conducting longer-term preclinical studies, up to and greater than 30 days of indwell time. The testing thus far has demonstrated the potential for superior clinical outcomes and lower healthcare costs compared with existing technologies.
Access Vascular expects to submit a 510K application to the FDA mid-year, with anticipated commercialization to launch as early as Q1 2018. The company recently moved into a state of the art facility and lab, where they will eventually manufacture the devices.
The HydroPICC is predicted to decrease morbidity, shorten hospital stays, advance treatment and improve the patient experience as well as reduce costs. While the HydroPICC will be the company’s first offering, they are in early stage development of hemodialysis access as well as implantable port devices. The aggregate venous access market is ripe for innovation as the current market leading products are less than ideal in their rate of thrombogenic and infectious complications. The combined market in the US is approximately $1.2B annually, and $3.5B worldwide.
angelMD is pleased to announce that we are opening a syndicate to raise capital for Access Vascular. If you are considering joining this exciting angelMD syndicate, please click on this link to be included in exclusive communications.
This past week angelMD’s CEO, Tobin Arthur sat down with Florian Martin of NPR for an interview about angelMD. A copy of the interview is posted on Houston Public Media. angelMD has an office at the Texas Medical Center’s Innovation Institute , located in Houston. With a rapidly growing health care innovation sector and the largest medical center in the world, Houston is the ideal location for angelMD’s unique expertise in early stage healthcare investing.
Listen to learn about how angelMD is a “matchmaker for innovators in the medical sector” here.
TMCx had another stellar turnout for the recent TMC Expert Forum highlighting their Spring 2017 class of 23 digital health startups.
Artificial Intelligence and outcomes tracking are a theme for many of these companies. All of the startups were impressive and have potential. However, I want to focus on those companies with proof of concept, marketability, scalability, and potential for investment.
- Lantern: a personalized mobile program that combines daily interactive lessons and professional coaching to strengthen emotional well-being. This company has proof of concept with a 40% reduction in symptoms such as stress/anxiety/eating disorders, high engagement with patients, and costs 1/10th of traditional therapies. They are currently implemented at more than 40 leading university employers and shown lower health claims and costs associated with co-morbid chronic conditions, disability, and employee absenteeism.
- WardMM.com: a decision supports analytics engine that provides evidence-based prescribing recommendations. Using a proprietary bio-builder algorithm that can clinically predict whether specific medications will affect outcomes before actually administering the medication to the patient. As the leading clinical service in Australia, this company has seen a 400% growth in revenue over the past 4 years.
- Medable: provides a fast path to secure HIPAA compliant healthcare applications/outcomes for researchers, startups, pharma, payers, and academia. As medicine continues towards an outcomes-focused approach, more payers will want outcomes based data from physicians to validate medical treatment. Proof of concept reveals a cost savings of 22% and a 90% participation rate/engagement from subjects. Overall <1% use mobile applications for conducting studies which provides better data acquisition and efficiency.
- Babyscripts: utilizing remote monitoring to better identify high-risk pregnancies determining the need for early intervention. Currently working with 10 health care systems. Proof of concept revealed a 10-fold increase in data collections which has led to fewer NICU admissions and early diagnosis of preeclampsia.
- NeuroLex: a voice analysis platform to detect health conditions before advanced symptoms appear. Utilizes over 200 measures within the voice to create a new biomarker for early detection of Parkinsons, Alzheimers, psychosis, and depression.
- SensorRx: a patient-centered application to improve outcomes for migraine sufferers. Data is collected and analyzed from sensors on the smartphone. A 6-month clinical trial revealed 90% utilization and 50% improvement in symptoms.
- DOT: EEG monitoring with a low-profile wearable device providing biofeedback for the diagnosis and treatment of neurobehavioral disorders such as ADHD.
- Personify Care: mobile platform enabling clinical teams to monitor patient recovery beyond the hospital stay. Helps identify complications or patients that need immediate follow up and can provide necessary protocols via smartphone. Proof of concept done and currently utilized in Australia.
- Arterys: automated, artificial intelligent software that uses real world clinical data to make radiologic imaging more accurate and data driven. One of the only FDA-cleared cloud database platforms. Proof of concept done with 41 active sites and 10,000 patients scanned.
These are a few of the companies that met the initial set of criteria. However, there were 14 other companies that were just as competitive but did not meet all of the pre-established criteria for our angelMD highlights. We look forward to many more companies to feature in our future blogs.
Stay tuned for follow up and investment opportunities in select companies as we approach Summer.
(Note: If your company is mentioned and you don’t yet have a profile created on angelMD then take 20 minutes and get it done. www.angelmd.co)
New syndicate for Chimera BioTechnology, Inc. a company that developed a unique hemostatic agent for pre-treating patients
angelMD is pleased to announce the formation of its newest syndicate for Chimera BioTechnology, Inc. (Chimera BioTech). Chimera Biotech is an angelMD company that developed a unique hemostatic agent for pre-treating patients to prevent or reduce blood loss in high risk surgeries, to treat diffuse surgical- and trauma-related bleeding and to treat spontaneous bleeding that occurs in the hemophilia patient population. angelMD had a chance to talk to Chimera BioTech’s CEO, Dr. Michael Griffith, and learn more about their important work.
We hope you enjoy this conversation. If you are considering joining this exciting angelMD syndicate, please click on this link, https://goo.gl/forms/sRK22PdDxrCap9YD2, to be included in exclusive communications.
1. What drew you to the field of hemophilia and blood coagulation?
I received a Ph.D. in biochemistry at the University of Texas Health Sciences Center in San Antonio where my research focused on the molecular interactions between enzymes and cofactors and took a coveted postdoctoral position at the University of North Carolina at Chapel Hill where the Center for Thrombosis and Hemostasis had been established. I joined clinicians and scientists who had begun piecing together the complex relationships between the enzymes and cofactors comprising what now is readily recognized as the coagulation cascade. It was an exciting time when new coagulation factors were being discovered and the scientific community was learning how interactions occurred that safely led to clot formation or went awry to cause life-threatening thrombosis.
The practical applications from the work we did in the lab quickly translated into practice within the clinical research setting at UNC. It was a special opportunity for me to contribute to the progress that was being made during the late 70’s and early 80’s.
2. For those less familiar with Factor VIIa and its clinical role, give an overview in a few sentences.
Factor VII is a coagulation protein that becomes activated when exposed to a vascular injury. Activated FVII (FVIIa) is known to be present in the circulation under normal physiological conditions, but only at a level corresponding to ~1% of unactivated FVII. This low level of circulating FVIIa is viewed as monitoring the lining of the vasculature for sites of injury and when encountered, then binds to a cofactor, referred to as tissue factor, that is exposed at the site of injury to kick off the explosive cascade of enzyme and substrate reactions that results in fibrin clot formation.
My mentor at UNC, Dr. Harold Roberts, in collaboration with a group of Danish colleagues, postulated that intravenously administering purified FVIIa to hemophilia patients experiencing a severe bleeding episode might overcome their coagulation deficiency to stop the bleeding. Twenty-plus years later, a commercially available recombinant form of FVIIa (NovoSeven; Novo Nordisk) is widely used to treat not only hemophilia patients, but also has been used off-label in an attempt to treat a wide variety of uncontrollable bleeding conditions within the hospital setting. However, due to its tissue factor binding properties, use of NovoSeven carries a catastrophic risk of thromboembolic complications, including pulmonary embolism and stroke.
3. How is Chimeric FVIIa, Chimera BioTech’s signature molecule, different than other proposed therapies for treating hemophilia and other difficult to control bleeding events in non-hemophilia patients?
We have cleaved the tissue factor binding region of Factor VIIa and replaced it with a homologous region from Factor IX. Thus, Chimeric FVIIa is a hybrid protein consisting of the hemostatically important functional regions of FVIIa without tissue factor binding properties. As a result, Chimeric FVIIa won’t bind to systemic tissue factor and cause aberrant thrombosis and thromboembolism. By removing this risk, we believe Chimeric FVIIa can change the intervention paradigm through early utilization for prevention of bleeding rather than as a treatment of last resort. Additionally, the region from Factor IX augments the attraction of Chimeric FVIIa to activated platelets at the site of vascular injury. These attributes of Chimeric FVIIa should improve outcomes, reduce patient risk for serious injury and death, reduce treatment costs and improve clinical outcomes.
4. What other applications are there for Chimeric FVIIa and what advantages will you offer in those markets?
The first market opportunity for Chimeric FVIIa is its use in treating hemophilia-related bleeding and we intend to seek market approval in this regard. Even though this is a crowded space, with several novel rFVIIa analogs and alternative approaches for improving the hemostatic capability of hemophiliacs in clinical development, the current rFVIIa analogs are not designed to reduce the dangerous thrombogenic potential for use in treating non-hemophilic bleeding and the safety and efficacy profiles of alternative approaches within the hemophilia setting are largely unknown. Chimeric FVIIa has an advantage over these competitors with its absent aberrant thrombogenicity.
The major market opportunity for Chimeric FVIIa is as a hemostatic agent for intravenously treating diffuse surgical- and trauma-related bleeding where safe and effective options do not exist today. Currently, when all standard methods of coagulation have failed, physicians may opt to use NovoSeven even though, there is a quantifiable thrombogenicity risk that leads to pulmonary embolism, stroke, or other morbidities. Since it is has been designed to eliminate tissue factor binding, Chimeric FVIIa does not carry these risks and should allow safe administration by physicians.
Perhaps the most exciting application of Chimeric FVIIa involves changing the paradigm of managing surgical and traumatic bleeding. We believe that early use of our product can result in a significant reduction in blood loss and possibly reduce or eliminate the need for transfusion. The mechanism for this pathway is the activation of Factors IX and X by Chimeric VIIa to increase thrombin production. This will “jump start” the process of hemostasis and reduce overall bleeding. The improvements in patients’ outcomes and cost savings will be great if Chimeric FVIIa becomes a gold-standard therapy in bleeding prevention in high-risk surgeries and traumas.
5. What third party validation have you received from the scientific community?
The company has applied for and received two small business innovation research (SBIR) award from the National Heart Lung and Blood Institute (NHLBI). As with other grant applications, the ChFVIIa research proposals were critically reviewed and approved by a study section of the NIH for scientific merit and for significance in advancing healthcare. Through a program sponsored by the NIH, two of our target markets, postpartum hemorrhage and bleeding in cardiovascular surgery, have been subjected to a third party assessment of the commercial opportunity for use of our product. These assessments have involved independent interviews of potential end-users and experts for each product application and in both cases, the feedback has been positive.
6. What interest in Chimera BioTechnology have you had from industry?
We have had preliminary discussions with pharma companies with a presence in the hemophilia treatment market. As I mentioned earlier, this is a crowded space for new product development and with pharma interest heavily weighted toward clinical-stage initiatives. It is noteworthy however that in cases where strong, preclinical hemophilic animal data has been generated, pharma interest can become quite intense. I can say this based on personal experience with my previous startup company, Inspiration Biopharmaceuticals, where multiple strategic partnership opportunities became available when we had established safety and efficacy in our hemophilic animal studies. Given this, we expect that by this time next year we will be in great position for discussions with established pharma companies.
7. How do you think syndicating an investment with angelMD will benefit Chimera BioTechnology?
AngelMD is a very attractive partner for us to work with at this time and probably for some time come. Our Chimeric FVIIa agent has a wide variety of potential uses in the treatment and prevention of severe bleeding and members of the AngelMD network have practical experience that can guide us in the design and execution of our clinical trials to obtain the best possible safety and efficacy data.
8. Tell us about your team and their unique capability in this specific field?
Chimera BioTechnology is my third startup company involving the development of products for treating and preventing both hemophilia and non-hemophilia bleeding in the past 14 years. A number of colleagues from my years of product development experience in the pharmaceutical industry and since have led to my access to a network of advisors and operations experts to call upon when the need has arisen. Individuals I have identified as my current operations team are colleagues I called upon to help me with my previous startup company, Inspiration Biopharmaceuticals (founded by John Taylor and Scott Martin). This team, with the help of a handful of exceptionally talented collaborators we subsequently brought on board, was able to drive product development from inception to a Phase 1 human clinical trial in 2 ½ years.
While the Chimeric FVIIa is a unique product, the development requirements are completely familiar to my team. I also have enlisted the services of two of my previous contractors who were responsible for developing my clinical product manufacturing process and conducting all product release and stability testing required for clinical use. At present, the services of the team are limited in nature as the company is focused on preclinical studies, but all members have signed agreements to ‘jump in’ when called upon (saving the company overhead costs until needed).
9. What are your key company goals for the next 12 months?
The next 12 months should be very exciting for us. Our recent results using animal models familiar to the scientific community have provided strong support for the efficacy of our product while demonstrating an undetectable thrombogenic potential. Our decision to migrate to studies involving the “gold standard” hemophilic dog model combined with our novel scientific approach for evaluating safety and efficacy in established animal models should generate compelling data to support the value of our product in humans.