Category: PLSG News

Meet our Companies: Medical Device Innovators in the PLSG Portfolio

Posted on by Jim Jordan

This is an exciting time to be involved in life sciences. Our industry is rapidly evolving. Some of that, of course, is connected to the shift in healthcare paradigms as dictated by policy changes and new business models. Another factor, however, is the rapid pace of health technology innovation. Here, at the Pittsburgh Life Sciences Greenhouse, we have the privilege of seeing some of these game changers grow from an idea into a company. In fact, we have worked with nearly 500 companies and scores of entrepreneurs in all aspects of life sciences: Biotech Tools, Diagnostics, Medical Devices, Therapeutics and Health IT. Today, we invite you to meet some of the medical device companies within our portfolio.

ALung Technologies

ALung Technologies respiratory assist system, called Hemolung (RAS), is for patients with acute exacerbations of chronic obstructive pulmonary disease, a $6.3B worldwide market. Clinical trials are currently underway.

Carmell Therapeutics

Carmell Therapeutics has developed plasma-based bioactive materials (PMA) that contain a concentration of natural regenerative factors that promote healing, reduce complications, and save healthcare costs. The company recently announced the publication of the results of its pre-clinical studies on its tissue healing accelerant for the treatment of cutaneous radiation injury.

Medrobotics

Medrobotics’ flagship product is the Flex® Robotic System, a robot-assisted platform that provides physicians with single-site access and visualization of hard-to-reach anatomical locations. Medrobotics co-founder Howie Choset was recently awarded the 2019 Engelberger Robotics Award for Education in part for his work on the Flex Robotic System.

Quantum OPS

Quantum OPS develops devices that facilitate the effortless, rapid, and secure positioning of a patients’ shoulder, arm, hip or knee for surgery. These devices can be used to safely support anesthetized patients in the proper position for several hours during surgery.

ViaTherm Therapeutics

ViaTherm Therapeutics is an industry leader in diathermy technology. Their therapeutic deep heating products can reduce the pain associated with injury and aging while helping to promote flexibility, mobility and assist circulation.

ChemDAQ Inc.

ChemDAQ Inc.’s toxic (sterilant) gas monitoring systems protect workers from exposure to airborne toxins. The system was originally used in hospital and medical device sterilization operations in the US. It has since expanded internationally and to other industries such as food and beverage processing, water treatment facilities and other industries that use Peracetic Acid, Hydrogen Peroxide or Ethylene Oxide.

Forest Devices

Forest Devices’ ALPHASTROKE helps first responders quickly identify whether a patient has had a stroke so they can route the patient to the proper hospital. This ability to identify and triage stroke victims in the field can reduce the time it takes to begin treatment. This is significant as early treatment can prevent up to 6,000 deaths per year.

Neuro Kinetics

Neuro Kinetics, Inc. (NKI) has developed a unique, eye-tracking technology to be used for non-invasive, neuro-otologic diagnostic testing. The company is expanding its applications to include concussions and is currently conducting clinical trials.

Circadiance

Circadiance has developed respiratory products for individuals with sleep-disordered breathing. These patients need non-invasive ventilation or require monitoring. The company has innovated a collection of comfortable, breathable, easy-care cloth respiratory products designed to improve the patient compliance rate. Circadiance’s NeoPAP CPAP is designed to treat newborns and infants with (or recovering from) respiratory distress syndrome.

Intelomed

Intelomed has redefined the standard of patient monitoring and informatics with their non-invasive device that dynamically assesses a patient’s cardiovascular health by analyzing pulse and pulse oximetry waveforms in response to small perturbations. The company has received FDA and European (CE Mark) approvals for their first product, CVInsight® Patient Monitoring & Informatics System.

PECA Labs

Created out of CEO Doug Bernstein’s personal experience with congenital heart defects, PECA Labs is developing a suite of products designed to improve outcomes for children born with rare congenital heart defects. For example, the company has developed a synthetic valve conduit for pediatric right ventricular outflow tract (RVOT) reconstruction and a valve shunt for the treatment of hypoplastic left heart syndrome (HLHS).  You can read more about PECA Labs and Doug Bernstein’s story here.

Rinovum Women’s Health

Rinovum’s product, the Stork™, aids in natural fertility and conception by “supported” natural conception conducted in the privacy of a patient’s home. The product is FDA-cleared to be used without a prescription and offers a low-cost alternative to clinical treatment options.

Starr Life Sciences

Starr Life Sciences is a leader in small animal research equipment. Their products include the MouseOx Plus® pulse oximeter, the world’s first and only patented non-invasive vital signs monitor specifically designed for mice, rats and other small laboratory animals.

These companies represent just one category of the PLSG portfolio. In addition to these innovative medical device companies, we also work with innovators that are disrupting the status quo in the areas of Therapeutics, Health IT, Diagnostics, and Bio Tools. You can learn more about those companies here.

PLSG Participates in Mentoring International Young Entrepreneurs

Posted on by Marissa Kuzirian

As a mentor to young professionals, hosting transatlantic partnerships represents a special honor. Transatlantic mentoring programs strengthen entrepreneurship in the U.S. and abroad. The Young Transatlantic Innovation Leaders Initiative (YTILI) connects European and Eurasian young entrepreneurs with U.S. mentors in cities across the country and is sponsored by the German Marshall Fund of the U.S. and the U.S. Department of State’s Bureau of European and Eurasian Affairs.

The 2018 YTILI Opening Summit in June, brought mentors and entrepreneurs together in Portugal, where participants discussed similarities and differences between the U.S. innovation ecosystem and European and Eurasian innovation ecosystems. Domain experts assisted fellows in fine-tuning pitch strategies and other related topics. YTILI fellows include young entrepreneurs between the ages of 24-35 with either commercial or social ventures that they are seeking to scale in their home countries. In 2018, 70 YTILI Fellows from Europe will benefit from mentorships at businesses, institutions, and civil society organizations across the U.S., building their networks and partnerships to help attract investments and support for their ventures. By experiencing new perspectives, YTILI fellows will also develop the expertise to better engage in policy conversations in their home countries, across Europe, and in the transatlantic market.

In October, Pittsburgh will host eight entrepreneurs with businesses ranging from bio-decontamination devices for healthcare, a global navigation satellite system correction provider, technology to produce rare parts for classic cars. During their one week stay in Pittsburgh, fellows will learn about Pittsburgh’s cultural and innovation ecosystems and meet with key members of the community to gain knowledge and connections, and to learn about entrepreneurship in the U.S.

Mentoring provides rich benefits not only for the mentee, but also for the mentor, as I have learned through YTILI, as well as Women In Bio’s MAPs program, and as a Brandeis Innovation Mentor. As a mentor, I have built strong relationships with individuals who have opened the door to their own connections when I have needed them. I have also learned from my mentees – from alternative ways to approach difficult situations to gaining deeper knowledge in subject areas important to the mentee. However, the most important benefit I have experienced as a mentor is the energy and inspiration of working with entrepreneurs who are pursuing their dreams and solving important problems.

International programs, such as YTILI, have an added benefit, as we can learn across cultures to foster creativity in finding solutions at home, here in Pittsburgh.

For more information on the YTILI Fellowship program, contact Marissa Kuzirian at the PLSG.

 

 PLSG Recognizes Advisory Board Member’s Selection to “30 Under 30” Class

Posted on by Delvina Morrow

 PLSG Recognizes Advisory Board Member’s Selection to “30 Under 30” Class

Carmelo Montalvo Serves on PLSG’s Under 40, Underserved Advisory Board

PITTSBURGH (July 31, 2018)—Carmelo Montalvo, a member of the Pittsburgh Life Sciences Greenhouse (PLSG) Under 40, Underserved Advisory Board, was recently named by the Pittsburgh Business Times to its 2018 “30 Under 30” Class of civic and business leaders.

 

The Pittsburgh Business Times “30 Under 30” Awards, is an annual celebration of young professionals who lead their generation and our region’s organizations and business landscape forward. In its second year, the 2018 “30 Under 30” class represents the next generation of leaders comprised of young professional across a variety of sectors who are reinventing our region for generations to come.

 

As a young professional, and transplant to Pittsburgh, Montalvo saw the opportunities of staying in the region and calling Pittsburgh home. In 2016, while completing his master’s at CMU in Healthcare Policy & Management and serving as a Defensive Line Coach for Tartan Football, Montalvo decided that he wanted to make an impact in the region by lending his talents and expertise to a life sciences startup. In 2016, Montalvo joined PLSG portfolio company Forest Devices as their Director of Operations.

 

Forest Devices created AlphaStroke, the first stroke screening device that can be used by medical personnel in any environment. Presently, 50% of stroke patients go to the wrong level of care, or a hospital without stroke care, adding an average delay of two hours. Such swift treatment eliminates delay, which can lead to negative outcomes, disabilities, and roughly $50 billion in healthcare costs in the U.S. Currently, as the Vice President of Operations for Forest Devices, Montalvo has navigated the company’s growth, and he has been instrumental in successfully closing an oversubscribed seed round of $2.3M in funding for the company’s future operations.

 

“Carmelo has played a key role in the company’s development, managing the day-to-day operations and developing standardized practices for both our product and project-management activities”. Said Matt Kessinger, CEO of Forest Devices. “Ever since joining the team, he has been willing to put his head down and get his hands dirty to accomplish goals, learn new skill sets, and promote our culture.”

 

Montalvo has provided his time, knowledge, and expertise to help move the region forward and to help advance the vibrant and growing life sciences community for entrepreneurs here in Pittsburgh. He serves as a conduit within the life sciences ecosystem through his community service, specifically within the PLSG’s Under 40, Underserved Advisory Board. As an Advisory Board member, he advises the PLSG on how it can capture and share life sciences knowledge to improve the success rates of its younger companies and entrepreneurs in obtaining capital and de-risking their programs.

 

Montalvo is a 2013 graduate of North Carolina Central University and obtained a master’s degree in Healthcare Policy & Management from Carnegie Mellon University in 2017. He was born in Brooklyn, NY and raised in New Bern, NC, and currently resides in Brookline with his wife and daughter.

 

About Forest Devices

Forest Devices is a medical device startup located in Pittsburgh, Pennsylvania. They are the creators of ALPHASTROKE, the first stroke screening device that can potentially be used by all medical personnel in any environment.  By re-purposing established technology, the team is developing a novel and objective stroke detection method. It would enable early and fast triage so stroke patients go to the appropriate level of care.  Providing a faster, safer, and cheaper alternative, over 2 million unnecessary emergency room CT scans could be averted every year. With thousands of deaths and billions in costs annually due to inadequate stroke detection, they are determined to become the new standard of care.

About the Pittsburgh Life Sciences Greenhouse (PLSG)

The Pittsburgh Life Sciences Greenhouse (PLSG) is a comprehensive life sciences economic development organization. We are dedicated to advancing life sciences in western PA by building on the region’s strengths in research, clinical care and life sciences entrepreneurship. We serve our community by providing knowledge, connection, and capital to help companies grow, create jobs, and improve the health of all humanity. For more information, please visit: www.plsg.com.

SAVE THE DATE – PLSG Presents the Life Sciences B2B Speaker Series: “Start-ups: Why and when to hire a lawyer?”

Posted on by Jeff Rhodes

For start-ups, it’s challenging to know when legal help is vital to ultimate success. Sure, outside legal counsel can be expensive, but sometimes getting it right at the start can save time, money, and headaches in the future.

Babst Calland, Attorneys at Law, can give you guidance. Founded in Pittsburgh and named one of the ‘Best Law Firms’ in 2018 by U.S. News & World Report, Babst Calland’s corporate and commercial law practice is comprised of business attorneys who have worked as entrepreneurs and corporate executives, as well as in-house counsel.

Come join Alana Fortna and Ben Milleville from Babst Calland for a constructive and practical discussion that will include such topics as:

• The pitfalls of going it alone with corporate governance documents
• When do you need a legal review of agreements?
• What are the basics for forming an entity and key agreements?
• What are key employment issues and associated agreements?
• How to protect your IP; NDA’s and other protections

The PLSG is pleased to sponsor a drawing for one legal service FREE of Charge![1] Any provision of legal services would require a formal engagement letter between Babst Calland and the client in accordance with the Pennsylvania Rules of Professional Conduct.

[Any provision of legal services would require a formal engagement letter between Babst Calland and the client in accordance with the Pennsylvania Rules of Professional Conduct.

Legal service choice: Incorporating a business, confidentiality agreement/non-disclosure agreement, or employment agreement/noncompete. You must be present at the time of drawing to win.

When:
Thursday, January 25th, 2018 from 5:30-6:30pm
Refreshments will be served.
Where:
Pittsburgh Life Sciences Greenhouse
2425 Sidney Street
Pittsburgh, PA 15203
412-770-1646

RSVP No Later Than January 23rd, 2018 by clicking on the following link to register:

http://events.constantcontact.com/register/event?llr=77km48kab&oeidk=a07ef0ub6iu0d5080cd

[1] Any provision of legal services would require a formal engagement letter between Babst Calland and the client in accordance with the Pennsylvania Rules of Professional Conduct.

 

 

The Innovation Ecosystem

Posted on by Jim Jordan

The “innovation ecosystem” represents a complex and interconnected journey, drawing heavily on initial research conducted at the university level, then moving through a chain of parties and decisions toward a goal of successful commercialization.  This diagram outlines the system and the role of each function, starting with identifying the two main components, technology creation and technology commercialization.

 

Technology Creation

The process starts with universities, entrepreneurs and corporations conducting various types of research, including: basic research to advance general knowledge; applied research to focus on a specific academic, commercial or business objective; or translational research that uses multi-disciplinary collaborations to make findings useful for practical applications to enhance human health.

Research feeds into development, where business and technical resources come together to offer a set of features and benefits in a product.  The outputs of R&D include invention, patents, and trade secrets (confidential information that provides a company with a competitive edge) to form the technology, or the specific set of features and benefits offered in a product.

In many cases, to prepare the technology to move from academia to industry requires additional research funding. Large corporations frequently invest in university research to develop more advanced technology more cost-effectively than doing it internally.

Technology Commercialization

Commercialization requires supporting activities such as service, distribution, logistics, meeting regulatory requirements, and so on.  It takes one of two forms, either corporations or startups.  Startups must simultaneously raise capital and plot a liquidity event that provides return for their investors, and must assemble a support network to bring the product to full commercialization.

Startup companies typically progress through stages of funding from seed to early-stage, then to growth stage and later-stage, before achieve liquidity for their investors by eventually being sold or selling their stock on the public markets. These monies come from various types of investors from friends and family, angel investors, venture capitalists, and corporate venture capital.

Incubators like PLSG provide a critical mechanism to assist startup companies as they participate in pre-seed, seed, and early-stage funding. Startups that tap into the power and viability of incubators enjoy a higher success rate in bringing their products to market.

The conclusion of a successful innovation cycle is a product available in the market, producing a profit, and providing a return for investors. With all these ingredients satisfied, the innovation ecosystem provides increased employment and a strong contribution to the economy.

# # #

 

Improving Consistency in Digital Health

Posted on by Jim Jordan

Digital Health is a complex system where ideas, trends, actions, and the ramifications that result, move at an ever-increasing rate of speed. In such an environment, it helps to have some level of consistency.  A set of rules, some generally agreed-to guiderails, that can keep forward progress moving while still enabling innovation and achievement.

That is why the U.S. Food and Drug Administration (FDA) recently announced establishment of a new digital health unit. Through this new group, the FDA and its Center for Devices and Radiological Health plan to ramp up medical app and device offerings, with the stated purpose of centralizing and coordinating digital health information so that there is consistency in applying policies.

Bakul Patel, associate director of digital health for the FDA, explained that the primary responsibilities of those on the project include developing software and digital health technology to assist with pre-market submissions or devices, utilize experts, and incorporate metrics that will assist with review times and submission.

This comes as welcome news for the life sciences industry, as it promises to provide some valuable structure, consistency, and direction to the burgeoning digital health marketplace, from inception of ideas through development prior to commercialization.

Creation of this digital health unit follows prior FDA actions to address this growing tech market, such as establishing guidelines for wellness apps in 2016, and cybersecurity guidelines for medical devices.

Later this year, the FDA plans to begin hiring as many as 13 full-time employees from various private sectors with hopes of having them on board by the 2018 fiscal year.

# # #

 

Micro Facts, Macro Truth and the Life Sciences EcoSystem

Posted on by Jim Jordan

In research, commercialization, business operations, and life in general, it’s important to realize and remember that select pieces of micro information do not necessarily add up to a Macro Truth, the complete picture.

Often times micro information, a Micro Fact, is mistakenly generalized to represent the whole. This is not necessary intentional, and indeed most of the time it is not. But the damage it can do in incorrectly portraying a universe is significant. In Life Sciences, to get a true picture of activity you must look at each segment of the entire pipeline – the Life Sciences Ecosystem –  not just one component.

Since 2002, the Pittsburgh Life Sciences Greenhouse (PLSG) alone has provided services to 468 companies and invested in 79 of these companies. Thirty-five of these companies were university companies, 12 of which were just in the past three years. Notably forty-four of these companies (56%) were not from the university. This is important because focusing on university companies alone as the benchmark is a Micro Fact. Even focusing on PLSG investments is a Micro Fact. For example, Grunenthal recently acquired Thar Therapeutics. Thar’s management team was provided early market research from the PLSG but they did not require funding and thus are not in our 79 invested companies. Additionally, Innovation Works and Idea Foundry Life Sciences investments must be included to get the true Macro Truth.

It frequently takes many technologies to create a single product. For example, inventing an automotive engine does not itself make a sellable automobile. It takes multiple components – crankshafts, braking systems, and so on. If the problem is getting from point A to point B, creating an engine helps, but it doesn’t solve the problem by itself. Even the invention of an automobile requires supporting infrastructure such as fuel stations, repair shops, etc. Although technology development is critical, it is only the beginning of the process.

In this same way, as we look at the Life Sciences Innovation and Commercialization Ecosystem, we cannot focus on just one segment for funding. Universities, Incubators and Entrepreneurs are all part of the Life Sciences Ecosystem. By focusing on just one segment, we lose perspective.

For example, research opens the door to commercial success, but it does not guarantee it.  Technology may be critical to commercial success, but it is only the beginning of the process.  It is not the complete process. What may be a factual statement discovered during the research phase of a project may have little bearing on the final product as it prepares to enter the market. Objective evaluation of factors must be balanced with a more subjective assessment of commercial appeal. An over-reliance on one side over the other can spell trouble.

It’s important to remember that even carefully selected Micro Facts may not necessarily yield a Macro Truth.  Entrepreneurs, investors, the media, and potential customers of life sciences companies must heed this truth for all to be successful in the Life Sciences Ecosystem.

# # #

Life Sciences Equals Economic Development

Posted on by Jim Jordan

Life Sciences drives economies, and for western PA it is one of our best contributors to economic development in the form of generating wealth and jobs. Just look at the math.

The term “life sciences” can include biotechnology, pharmaceutical, diagnostic, medical devices, and health care IT products – which make up approximately 40% of health care spending. And our nation’s health care system is projected to be $3.2 trillion by the end of the year. When you do the math, that’s $1.3 trillion in life sciences.  And that’s just the U.S.

In short, success in the life sciences is necessary for prosperity in a region, state, or nation.  We’re not talking about a subjective observation.  This statement comes via cold, irrefutable, objective calculations.  The economic impact of the life sciences industry is simply too big to ignore and too important not to invest in heavily.

Our local universities attract nearly $1 billion of federal funding each year to the region. That means if we were a state, the economic impact of western Pennsylvania’s federal funding for life sciences research alone would rank us among the top 12 states in the country.  That sounds big, and it is.

Lastly, the PLSG and its central role in fostering and advancing the life sciences in this region would not be in possible without foundation support.  Funding from regional foundations can be directly linked to an annual increase in Pittsburgh-area life sciences startups from three companies in 2002 to more than 12 today.  While we always would like to see more funding to support the innovation coming from our universities and entrepreneurs, the fact remains that our local foundations have been invaluable in moving the needle higher.

A high level of cooperation among investors, foundations, university researchers and technology transfer offices, local entrepreneurs, and organizations like PLSG is essential for success.  We must all focus on the same result – to generate economic prosperity, increased jobs, and a higher quality of life for our families, all through a stronger, more vibrant, and ever-expanding life sciences presence across this region.

Alpha Lab Demo Day – It’s Personal

Posted on by Jim Jordan

Today, Innovation Works’ Alpha Lab Demo Day brings our community together to celebrate innovation and to reward the hard work of those who present their companies.

Each year, as I did this morning at 7 am, I text Rich Lunak, President of Innovation Works, “It’s my favorite day of the year.” I know he appreciates the sentiment, but I equally wonder if he privately thinks I’m exaggerating: I’m not.

I moved to Pittsburgh twelve years ago. This day consistently validates that this has been one of my most important life decisions, by concisely exemplifying what Pittsburgh has created: a community working together to achieve economic prosperity both for ourselves and for the region.

This wonderful energy has also seeped into my home. I have pulled my daughters from school to attend Alpha Lab Demo Day, because witnessing this event is monumental. It provides an opportunity to share what Pittsburgh has to offer. I wanted them to see the diversity of the talent on the stage, in both the ideas of the presenters and in their varied backgrounds. Alpha Lab Demo Day also shares its spotlight and appreciation for the entrepreneurial ecosystem that is required to get these companies funded and exited. This energy of innovation attracts the universities, the investors, and most notably this year with Philips in attendance, the acquirers.

My youngest daughter Julia, who has attended Alpha Lab Demo Day, will attend the University of Pittsburgh School of Nursing in the fall. Julia had numerous acceptances from other prestigious schools such as Case Western and George Washington; however, she chose Pittsburgh because of the support and research opportunities we have here. This was first witnessed when she was a sophomore in high school at Alpha Lab Demo Day, and subsequently reinforced with the resources of Pitt’s Innovation Institute.

So, Mr. Lunak, it really is my favorite day. Your leadership, well-supported by the daily efforts and passion that Jim Jen and Ilana Diamond put into this program as well, has impacted my life and that of my family.