Category Archive For "Startup Spotlight"
PrimeVax is a pre-clinical biotech company who has developed a one-time one-week cancer treatment for late stage, non-responding patients using wild type dengue virus and autologous dendritic cells. They expect to enter their first clinical trial in 2017.
To learn more about this exciting angelMD company and be the first to know about investment opportunities, please follow them on angelMD.
The idea of harnessing the power of the immune system to battle cancerous tumors is not new. A recent BBC article, Cancer: The Mysterious Miracle Cases Inspiring Doctors, discusses one of the strategies that PrimeVax, an angelMD company, is taking.
The BBC article references a case study of William Coley, who famously observed a patient with a large tumor in his neck experience spontaneous remission after catching a nasty skin infection. He tested the principle on a small number of other patients, and found that deliberately infecting them with bacteria or other toxins destroyed otherwise inoperable tumors.
Indeed, recent evidence makes a compelling case that infection can be the key to stimulating spontaneous remission. For instance, per the BBC article,
Rashidi and Fisher’s study found that 90% of the patients recovering from leukaemia had suffered another illness such as pneumonia shortly before the cancer disappeared. Other papers have noted tumours vanishing after diphtheria, gonorrhoea, hepatitis, influenza, malaria, measles, smallpox and syphilis. What doesn’t kill you really can make you stronger in these strange circumstances.
The article goes on to point out that the microbes themselves aren’t directly responsible for the healing – the infection is thought to trigger an immune response that affects the tumor.
Further excerpts from the BBC article are below:
It’s not the microbes, per se, that bring about the healing; rather, the infection is thought to trigger an immune response that is inhospitable to the tumour. The heat of the fever, for instance, may itself render the tumour cells more vulnerable, and trigger cell suicide. Or perhaps it’s significant that when we are fighting bacteria or viruses, our blood is awash with inflammatory molecules that are a call to arms for the body’s macrophages, turning these immune cells into warriors that kill and engulf microbes – and potentially the cancer too. “I think the infection changes the innate immune cells from helping the tumours to killing them,” says Henrik Schmidt at Aarhus University Hospital in Denmark. That, in turn, may also stimulate other parts of the immune system – such as our dendritic cells and T-cells – to learn to recognise the tumorous cells, so that they can attack the cancer again should it return.
Schmidt thinks that understanding the process of spontaneous remission is vital, since it could help refine the emerging class of “immunotherapies” that hijack our natural defences to combat cancer. In one treatment, for instance, doctors inject some cancer patients with inflammatory “cytokines” in order to kick the immune system into action. The side effects – such as high fever and flu-like symptoms – are typically treated with drugs like paracetamol, to improve the patient’s comfort.
But given that the fever itself may trigger remission, Schmidt suspected that the paracetamol might sap the treatment’s potency. Sure enough, he has found that more than twice as many patients – 25% versus 10% – survive past the two-year follow-up, if they were instead left to weather the fever.
There could be many other simple but powerful steps to improve cancer treatment inspired by these insights. One man experienced spontaneous remission after a tetanus and diphtheria vaccination, for instance – perhaps because vaccines also act as a call to arms for the immune system. Along these lines, Rashidi points out that a receiving standard vaccine booster – such as the BCG jab against tuberculosis – seems to reduce the chance of melanoma relapse after chemotherapy.
Catching a Cure
Others are considering a far more radical line of attack. For instance, one approach aims to deliberately infect cancer patients with a tropical disease.
The technique, developed by American start-up PrimeVax, involves a two-pronged approach. It would begin by taking a sample of the tumour, and collecting dendritic cells from the patient’s blood. These cells help coordinate the immune system’s response to a threat, and by exposing them to the tumour in the lab, it is possible to programme them to recognise the cancerous cells. Meanwhile, the patient is given a dose of dengue fever, a disease normally carried by mosquitoes, before they are injected with the newly trained dendritic cells.
Under the supervision of doctors in a hospital, the patient would begin to develop a 40.5C fever, combined with the widespread release of inflammatory molecules – putting the rest of the immune system on red alert. Where the tumour was once able to lurk under the radar, it should now become a prime target for an intense attack from the immune cells, led by the programmed dendritic cells. “Dengue fever crashes and regroups the immune system, so that it is reset to kill tumour cells,” says Bruce Lyday at PrimeVax
Infecting vulnerable patients with a tropical illness may sound foolhardy, but dengue fever is less likely to kill the average adult than the common cold – making it the safest choice of infection. Importantly, once the fever has subsided, the programmed immune cells will remain on the lookout for the tumour, should it reappear. “Cancer is a moving target. Most therapies attack from just one side – but we’re trying to put it in a lose-lose situation, now and in the future,” says Lyday.
No one could fault the ambition behind this kind of therapy. “Our mission is to replicate spontaneous remission in as standardised way as possible,” says Lyday’s colleague Tony Chen. Even so, they are keen to emphasise that their idea is still at a very early stage of development – and they cannot know how it will play out until they begin a clinical trial. The first tests, they hope, will begin with advanced melanoma patients, perhaps by the end of the year.
Clearly, caution is necessary. As Irvine points out: “Spontaneous remission is a little clue in a big complicated jigsaw.” But if – and that is a massive if – they succeed, the implications would be staggering. A rapid, relatively painless recovery from cancer is now considered a miracle. The dream is that it might just become the norm.”
With the advent of immune-oncologic agents, we are entering a brave, new era of cancer therapeutics. Several companies already have seen early clinical and commercial success with treatments that target a facet of the immune-modulated innate response to tumors. Thus, there is no doubt that the future of anti-cancer therapy lies in harnessing the power of the immune system. PrimeVax is poised to enter this exciting market with a unique approach that is poised to play an important role in treating cancer.
If you’d like to know more about this exciting angelMD company, please follow PrimeVax on angelMD to be included in exclusive communications about progress and investment opportunities.
Fibralign Corporation is a Stanford spin-out that produces advanced therapeutic biomedical devices utilizing its patented Nanoweave™ technology for fabricating 3D scaffolding which precisely mimics human tissue structure.
angelMD is currently circling investment for a potential Fibralign syndicate. If you’re interested in investing in this innovative company, please let us know here.
AngelMD had a chance to talk to Fibralign's CEO, Greg King, and learn more about their important work. We hope you enjoy this conversation. If you'd like to know more about this exciting angelMD company, please visit this link to be included in exclusive communications.
Can you tell us more about BioBridge?
The BioBridge™ Collagen Matrix is a thread-like scaffold made of highly purified collagen which has been shown to promote and direct new vessel formation (angiogenesis and lymphangiogenisis). The product that took over three years to develop in collaboration with Stanford and received 510(k) clearance last year for use as a surgical mesh for soft tissue repair. We are completing an initial “first-in- women” clinical study in the Dominican Republic treating patients with breast cancer related lymphedema and are about to start a larger clinical study with Stanford. The Stanford study will be applied to expand the 510(k) indication for use of BioBridge to include lymphatic tissue and provide data for marketing for this treatment.
For those less familiar with secondary lymphedema and its current therapies, can you discuss why this is an important target?
We chose lymphedema for BioBridge’s first focus because it is truly a large unmet need with no cure. Secondary lymphedema develops when the lymphatic system is disrupted and unable to transport interstitial large fluid away from a region of the body. It is characterized by gross swelling of the affected limb accompanied by fibrosis, resulting in serious infections (cellulitis and skin ulcers) and can lead to severe deformity, and even amputation. Secondary lymphedema in western countries most commonly occurs as a delayed result of cancer treatment, particularly in breast cancer patients where an estimated 15-30% of patients are impacted. Metastatic tumor cells can frequently spread via the lymphatic vascular system and colonize lymph nodes, necessitating radical surgery that often destroys lymphatic vessel networks and impairs lymph drainage.
Conventional therapies (compression garments, physical therapy, massage, etc.) that are commonly used can be helpful in reducing discomfort, but treat only symptoms. These therapies are time consuming, provide limited relief and are costly — mostly paid for out of pocket. Since they require great persistence, often with diminishing returns over time, many patients give up in frustration and stop treatments. Surgical procedures have been more recently deployed as part of reconstruction surgery, but with limited success, relegating most patients to conventional therapies.
How is BioBridge different than other proposed therapies for treating secondary lymphedema?
BioBridge will be used to support surgical intervention of lymphedema by providing soft tissue support that allows for restoration of lymphatic function. BioBridge is a medical device that has been designed to be implanted subcutaneously in the diseased area as a temporary scaffold and, since it is made from purified medical-grade atelocollagen (without any additives), made to safely resorb in 6-9 months.
Based on our engagement with KOLs in this field, we anticipate that BioBridge will be used in different surgical approaches by oncologists and plastic surgeons to both treat and prevent secondary lymphedema. The clinical study with Stanford will be evaluating the therapeutic effect of BioBridge as an adjunct to autologous lymph node transfer (ALNT). ALNT surgery is a microsurgical procedure that has grown recently in popularity where a patient’s healthy redundant lymph node is transplanted as a free flap to the diseased area. Transplantation of healthy tissues, to reverse the loss of lymphoid tissue and function, has shown some improvement in limb edema with evidence of lymphatic re-routing and clinical evidence of spontaneous lymphatic regeneration. Although this procedure has been shown to provide some benefit in human lymphedema patients, autologously transplanted lymph nodes incorporate into existing lymphatic vasculature at a low frequency and failure of the transplant to integrate into existing lymphatics compromises the outcome. It is expected that BioBridge will address a fundamental weakness in this procedure and substantially improve surgical outcomes to make this an effective treatment for patients.
What other applications are there for the patented Nanoweave™ technology and what advantages will you offer in those markets?
While our primary commercial focus is making BioBridge successful for treating lymphedema, we are developing a pipeline of other circulatory disease applications (peripheral artery disease, CLI, myocardial infarction), nerve repair/regeneration and as a novel drug/cell delivery device. BioBridge provides the opportunity to address these chronic diseases Current treatment options available for these chronic diseases are lacking and Fibralign’s approach provides the means to promote and direct regeneration to repair tissue (angiogenesis, arteriogenisis).
BioBridge’s capabilities can also bring significant value to delivery applications by increasing cell survival, localizing delivery, improving efficiency and enhancing the regenerative process. Through our collaboration with Stanford we have demonstrated that BioBridge provides a 3D structural template that provides instructive cues to enhance cell survival, proliferation and differentiation. We have also been working with Stanford and the VA on a DoD-funded project to use BioBridge as a solid state delivery device for gene therapy (HGF mmRNA) that will be used for muscle loss/repair and vascular regeneration. Regulatory approval cycles are expected to be more involved for such combination devices but are expected to provide substantial follow-on opportunities.
What third-party validation have you received from the scientific community?
The Company has collaborated with leading researchers (Stanford, UCSF, others) that has resulted in published pre-clinical studies which validated BioBridge and the Nanoweave technology for regenerative medical applications. These efforts included successfully completed a six-month translational large animal lymphedema study with Stanford (DoD funded) that demonstrated the efficacy and safety of BioBridge. This published study, the first of its kind, showed definitively that BioBridge promoted formation of new functional lymphatic vessels and restored lymphatic function. The published study results showed definitively that in animals with lymphedema, implantation of BioBridge (1) normalized or reduced the extracellular liquid volume and (2) increased the number of functional lymphatic collectors, which was accompanied by (3) BioBridge integration into irradiated tissue and (4) formation of new microvasculature with increased lymphatic fraction in the proximity of the scaffold.
Fibralign is also carefully evaluating other future product opportunities that would benefit greatly from its core Nanoweave™ technology. The Company has engaged in select development projects with industry and university collaborators that are expected to result in forward commercial products.
What interest in Fibralign have you had from industry?
Fibralign has attracted strong interest and support from KOLs in this field, including clinicians, oncologists and microsurgeons, as well as from patient groups and national and international lymphedema organizations. The Company have been engaged with KOLs and participated in lymphedema-related medical and scientific conferences over the past three years and have interest generated throughout the US, Europe, Japan, China, Taiwan, Russia and India.
Industry partnering is an important strategy for both advancing commercial engagement and for licensing our core technology for other applications. However, at this stage, we are mainly focused on our initial product. But we have maintained ongoing select and funded development programs with industry and currently in discussions with a large medtech company about a potential strategic relationship. We certainly plan to engage others going forward.
How do you think syndicating an investment with angelMD will benefit Fibralign?
angelMD provides a unique opportunity to engage medical professionals who can appreciate the potential of Fibralign’s core technology in helping to address unmet medical needs and provide value beyond the investment. We are excited about engaging members of the network in ways that will help us build a successful company and provide guidance in developing a pipeline of opportunities in other specialties, such as orthopedics.
Tell us about your team and their unique capability in this specific field.
Fibralign has assembled a strong, multi-discipline, cross-functional team that consist of eight full-time and seven part-time members whose deep experience span across biotech, engineering, materials science, operations, process development and market/business development. Team members have worked in relevant biotech GLP/GMP commercial enterprises, spanning process development (Collagen Corp.), biomedical engineering, product development and QA/QC (J&J DePuy Synthes).
Consultants have been engaged to bring special industry skill sets where needed (e.g., collagen development, cross-linking, regulatory affairs, reimbursement, document/QA management, IP management, engineering development). The Company has an active Board of Directors that have started and been involved in successful healthcare startups (exits >$100m, successful IPOs) and an active Scientific/Medical Advisory Board.
This team has advanced development of BioBridge to reach commercial readiness. This included significant efforts in product development (finalizing specifications, qualifying source of materials, SOPs, packaging and extensive GLP toxicology and biocompatibility testing) that were required for 510(k), which was received in 2016. Fibralign has since completed transfer to manufacturing in support BioBridge’s commercial launch and the proposed clinical studies. These efforts included finalizing all manufacturing tooling/modules, end-to- end GMP process, documentation, securing cleanroom certification, QMS, sterilization validation and completing formal QSR and Design Reviews.
Our newest team member who just joined us in February, 2017 Dimitris Dionysiou, MD, PhD as our Chief Medical Officer. Dr. Dionysiou is a renowned microsurgeon and researcher in this field that has significant clinical experience and published studies regarding lymph node transfer procedures. He came to Fibralign from his role as Assistant Professor in Plastic Surgery (Clinical) at the Aristotle University of Thessaloniki, Greece.
What are your current status and your key company goals for the next 12 months?
Our key goals for 2017:
- Initiate the Stanford led clinical study, which will take about 18 months to complete and is expected to involve at least one additional site
- Secure CE mark for BioBridge, initiate clinical study in Europe
- ISO 13485 Certification (required for CE mark)
- Expand manufacturing capability to support initial sales
- Advance development of BioBridge for use as a combination device (cell delivery, gene therapy)
angelMD is currently circling investment interest for a potential Fibralign syndicate. If you’re interested in investing in this innovative company, please follow them on angelMD and visit this link to request more information.
A few days ago McNair Hall at Rice University was buzzing with anticipation and energy as many of the entrepreneurs scurried about putting the final touches on their presentations getting ready for the elevator pitch event. Every year contestants from across the globe merge together for this special event that crowns one winner with a cash prize and connections worth over a million dollars. Now the hallways are empty and the grand prize has been earned by Forest Devices, a startup company with a novel technology that allows medics, ambulatory personnel, and physicians to screen for stroke quickly and efficiently.
The Rice Business Plan Competition has become one of the most sought-after competitions within the startup world. This year 42 companies competed, with a staggering 21 of these companies within the healthcare market.
As a healthcare provider and entrepreneur I wanted to highlight ten niche-specific companies that I found great potential in tackling a specific problem within healthcare.
A minimally invasive percutaneously placed device that allows cardiologists to create a pressure relief shunt between the atria to provide continuous and dynamic decompression. The problem addressed is heart failure with the advantage of not using stents or anticoagulants. Animal studies with two design firms to finalize product development are upcoming.
Helping healthcare providers customize the right treatment for each patient by utilizing Artifical Intelligence-derived algorithms.
RBPC 2017 winner. Creators of AlphaStroke, the first portable device that screens for stroke across all point-of-care environments and can be used by all medical personnel. See above.
Creators of a small molecule therapeutic (Nivien) that defeats several resistance mechanisms at once. Pre-clinical data predicts Nivien could double the survival rate of metastatic pancreatic cancer patients. Currently working on IND status with the FDA.
A novel US patented non-invasive intraocular pressure monitoring system within a contact lens. Helps identify patients with undiagnosed glaucoma. Finalizing the prototype ahead of FDA approval.
Innovative load bearing magnesium implants that are biologically absorbed instead of having to be removed after the bone has healed. Currently preparing for FDA approval. Regulatory approved for first and second product in Europe.
A tissue engineered scaffold that enables patients to regenerate, with their own cells, an innervated nipple with natural pigmentation and projection after mastectomy. Completing animal studies with human studies to follow.
An add-on device that will reduce Catheter Associated Urinary Tract Infections (CAUTIs) by continuously killing harmful bacteria using light systems. Currently working on prototyping, testing, and FDA approval.
A remote wound monitoring system that wirelessly sends vital signs (pH levels, bacteria presence, bleeding, infection, etc) to remote medical staff and doctors to provide early signs of infection/ ulceration/ bleeding in real-time. Clinical trials and regulatory approval underway.
An integrated smartphone platform where field workers can acquire patient or environmental samples, detect the disease using proprietary algorithms, and report results in real time with geo-tagged data. The technology provides rapid results allowing quicker reactive responses to outbreaks and early disease detection. Currently undergoing field testing with cholera and malaria testing platforms.
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J. Michael Bennett, MD
Regional Medical Director, angelMD
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.