AngelMD Portfolio Company Raydiant Oximetry Awarded FDA Breakthrough Device Status

In the United States, roughly one out of every three babies born in the United States are delivered via cesarean section. According to key stakeholders, nearly half of these c-section deliveries are medically unnecessary. These major surgeries carry risks such as postpartum hemorrhage, rupture of the uterus, cardiac arrest, infection, complications from anesthesia, and much more.

Raydiant Oximetry, Inc. is a California-based company that has developed a safe and noninvasive technology that directly monitors a baby’s oxygenation during pregnancy. For clinicians who are dissatisfied with the lack of tools available to assess the baby during childbirth, this technology will lead to improved decision making and better care to mother and baby. Today, the company is announcing that it has been awarded Breakthrough Device status by the Food and Drug Administration (FDA).

“The FDA’s approval for a Breakthrough Medical Device status is an incredible validation for the work that we are doing,” said Raydiant Oximetry CEO Dr. Neil P. Ray. “Not only does it accelerate the path towards FDA approval, it’s also a public health validation that what we have been developing is a global priority for the health of mothers and babies.”

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The FDA’s Breakthrough program is targeted towards medical devices that address significant unmet clinical needs. It provides an expedited pathway to approval for market access. This pathway affords the sponsor a priority review with senior personnel and less pre-market clinical data for expedited approval.

“It is baffling that the public outcry over our current c-section rate isn’t louder than it is,” said AngelMD Lead Investor Dr. Wendy Whittington. “Raydiant’s new breakthrough status confirms that safe, effective tools to give doctors better information about in utero well being are necessary and timely. Tools to enable doing the right thing are welcome and necessary in this pivotal time for our healthcare system.”

AngelMD announced in September 2018 that a group of its investors had completed a funding round in Raydiant Oximetry. The company is now working on building its next generation prototype, to improve accuracy and reliability, which is slated for completion in February of 2019.

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AngelMD Investor Group Completes Funding Round in Access Vascular

Today, AngelMD is announcing the close of a $594,000 round of funding for Access Vascular, Inc. The syndicate funding is part of the total $3.4 million round that has now been closed by the company.

A peripherally inserted central catheter (PICC) is a critical component to long-term intravenous treatments. However, the status quo for PICC equipment has an inherent problem — the potential for deep vein thrombosis and pulmonary embolism. These conditions can occur because blood platelets begin to deposit on the PICC’s surface immediately after placement. Based in Massachusetts, Access Vascular has developed the HydroPICC — a PICC developed with proprietary bulk hydrophobic material which is highly resistant to platelet deposit.

“We are grateful for the support that our new and existing investors have given us as we prepare for the roll-out of our first product,” said Access Vascular CEO James Biggins. “In addition to funding the initial post-market use of our FDA-cleared HydroPICC, the funds will support the development of other products in our pipeline. This includes a version of our device that may be capable of controlled release of drugs over an extended period of time to actively kill bacteria over the lifespan of the device.”

Access Vascular has recently passed a number of milestones on its route to market release. In September, the company released the results of its preclinical studies. These studies showed that in in-vitro and in-vivo use, Access Vascular’s HydroPICC achieved a 97 percent reduction in thrombus accumulation versus existing market options.

“I first became aware of the company through AngelMD. Access Vascular has met a huge need for vascular catheters that do not clot and cause complications for patients,” said Syndicate Lead Dr. Min Yoon. “CEO James Biggins discussed the technology in depth, and had a clear strategy to provide a return to shareholders.”

The company intends to begin a limited market release in October of 2018. This release will signal the first commercial use of the device.

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AngelMD Investor Group Closes Funding in Neumentum, Inc.

More than 115 people die from overdosing on opioids each day in the United States. While opioid addiction itself is nothing new, increased opioid prescription rates since the 1990s have only exacerbated the opioid epidemic, which has officially been declared a public health emergency. Neumentum, Inc. is a California-based company that is developing and plans to commercialize products that have the potential to effectively treat pain, without the risks of abuse, misuse and diversion seen with opioid analgesics.

Today, AngelMD is announcing the close of its latest syndicate investing in Neumentum. The company intends to use the capital to accelerate and complete a Phase I pK study and prepare and initiate Phase III clinical trials for its lead product candidate, NTM-001. NTM-001 is a novel, alcohol-free formulation of the non-steroidal anti-inflammatory drug (NSAID) ketorolac in a pre-mixed bag designed for 24-hours of continuous infusion following surgery. It is being evaluated to manage moderately severe acute pain that requires analgesia at the opioid-level, usually in a post-operative setting, potentially reducing the need for opioid pain relievers.

“Neumentum is developing new ways to manage pain without the risk of addiction, misuse or life-threatening side effects seen with opioids. We believe that people in pain deserve alternative treatment options that are more effective and safer than those widely available today,” said Scott Shively, co-founder and chief executive officer of Neumentum. “We are proud to have the support of the AngelMD syndicate and are honored to partner with such a prestigious investor platform. The confidence the physicians that comprise the AngelMD syndicate have in our company serves to bolster the potential for what could be the first continuously infused NSAID to be successfully developed for acute post-operative pain in the US.”

The Phase I study of NTM-001 is designed to evaluate the pharmacokinetics of NTM-001 continuous infusion compared with ketorolac IV injection every 6 hours. The study will be comprised of 4 cohorts and will enroll 64 subjects at two sites.

“As physicians, we’re taught to treat the fifth vital sign of pain — a practice which may have caused the opioid crisis that we’re now dealing with,” said Syndicate Lead Investor Dr. Suzanne Manzi. “There are no studies that show proven efficacy of opioids for treating chronic pain. Neumentum may have an answer that helps to shift the paradigm of post-operative pain control to a non-opiate solution.”

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Introducing AngelMD Premium for Physicians and Investors

Over the past few months, you’ve probably seen us talking about AngelMD Premium. It is a program designed specifically for AngelMD physicians and investors. To answer the inevitable questions about AngelMD Premium, I wanted to take a few minutes to explain each of the benefits, and why we chose them.

First Look

Premium members are given the first opportunity to invest (and to lead investments) on the AngelMD network. We know how important deal flow is to the success of every investor, so AngelMD Premium ensures the best possible deal flow in the world of healthcare startup investing.

AngelMD Insights Reports

In order to make sure that AngelMD members see the most promising startups, we spend time reviewing each one that signs up to the network. As a byproduct of this work, we are able to spot trends that not only impact the population of AngelMD, but also the healthcare landscape as a whole. Our Insights Reports are a listing of key findings when they are most relevant.

Investor Insider Webinar

Each month, you’ll be invited to our Investor Insider webinar. The AngelMD team will spotlight startups that are capturing the most feedback on the network, as well as companies that are about to enter the syndicate investment process. It’s your chance to get a “heads up” on what’s coming into the pipeline, and ask questions directly to AngelMD’s Investment Operations staff as well as the startup CEOs.

Quarterly Healthcare Investment Report

In Q1 of 2018, there were nearly 700 individual Form D investment filings submitted to the SEC. The AngelMD team distilled these filings, surfacing the trends, categories, and investment sizes that made the most impact so far this year. Each quarter AngelMD Premium members get full access to our Healthcare Investment Reports, helping them to stay informed so that they can make data-driven investment decisions.

Starup Insider Podcast

Each month AngelMD interviews entrepreneurs, giving our Premium members a recorded program that showcases innovation while addressing funding and other challenges associated with starting a new company.

Alpha Conference Discounts

AngelMD Premium also provides a steep discount to Alpha Conference, our unique gathering of healthcare innovators, inventors, and entrepreneurs focused on early-stage medical startups. The next event will be held in Monterey, CA on January 3rd, just prior to the JP Morgan Health Care Conference. The conference fee is $1,250 but discounted to $375 for AngelMD Premium members that register early. Premium members also receive a highly discounted companion pass.

AngelMD’s website, newsletter, and blog will stay free for investors, physicians, and startups. These elements are focused on helping our members learn how to be better angel investors, and how they can impact healthcare beyond their practice through advising and investing in promising companies that they believe in. AngelMD Premium is our offering to help offset the costs associated with producing detailed, extensive reports and insights that our most serious member-investors have requested.

Thanks for reading, and I look forward to hearing your feedback.

AngelMD Premium is for Physicians and Investors

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AngelMD Completes Investment in Saranas

AngelMD announced the close of follow-on investments in Saranas, Inc. This is the second AngelMD close for Saranas, as the network continues its approach of maintaining lifelong support for its portfolio companies.

Saranas is a Houston-based company that is developing fast, accurate diagnosis of complications related to vascular access procedures. Over 20 million patients are treated via vascular access each year, and over a million suffer from life-threatening complications that Saranas is helping to solve.

“Saranas is excited to have AngelMD once again participate in our financing round. With AngelMD’s vast physician network and counsel, we aim to deliver a product that has the potential to significantly reduce bleeding complications while also reducing related costs to providers and the healthcare system,” said President and CEO Zaffer Syed. “Since our last round of financing, we have completed design verification and validation activities, continued to build our growing intellectual property portfolio, and submitted a De Novo application to the FDA. With this investment, we are well positioned to initiate a multicenter clinical pilot and extend access to this innovative device to patients in the U.S.”

Saranas originates from the Texas Heart Institute at the Texas Medical Center. The company provides real-time monitoring without radiation, at reduced costs from the status quo.

“We’re proud to play a continuing role in the success of Saranas,” said Dan Pars​le​y, AngelMD President. “Building the world’s largest network of physicians, investors, and cutting-edge medical technology startups places AngelMD in a uniquely advantageous position. Investments like this are the byproduct of having incredible deal flow, minimizing risk for investors, and using the combined knowledge of the best physicians in their respective fields.​ In this case, our Interventional and General Cardiologists played a large part in evaluating the potential of this device.​”

AngelMD member-investors continue to play an integral part in the success stories of companies within the network. By not only investing, but also by evaluating and advising companies, the AngelMD process helps to mitigate risk while increasing potential returns and facilitating better outcomes.

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