October 05, 2015

Miami startups Biscayne Pharmaceuticals, Insero Health merge

Two young Miami-based biopharmaceutical companies, Biscayne Pharmaceuticals and Insero Health, already shared a lead investor and executive chairman, as well as office space on Biscayne Boulevard. On Monday they announced that they merged, giving the combined company two areas of focus.

Biscayne Pharmaceuticals is a clinical-stage company developing therapies for drug-resistant cancers, and its technology is licensed from the University of Miami. Insero Health is focused on treatments for epilepsy, pain and other central nervous system disorders. Dr. Stephen Collins, formerly CEO of Insero Health, has become CEO of Biscayne Pharmaceuticals. Samuel Reich, a Miami Beach healthcare investor who co-founded both Biscayne and Insero Health and most recently was CEO of Biscayne, will retain the position of executive chairman of the combined companies. Financial details of the transaction were not disclosed. The combined company, which will be called Biscayne Pharmaceuticals, has about five employees plus contractors.

Insero was co-founded by Harvard neurology professor and epilepsy expert Dr. Steven Schachter, and Biscayne’s cancer program is based on the work of Nobel laureate Dr. Andrew Schally, an endocrine researcher and prolific drug developer, said Reich. “Biscayne now is in the enviable position of having two novel platforms with excellent proprietary protection championed by world class scientists and targeting refractory conditions with major unmet needs,” he added.

July 17, 2015

MDLIVE leads state in venture funding in 2nd quarter

South Florida companies attracted most of the state's venture capital funding, according to the MoneyTree Report. Nationally, AirBnB was the top deal -- $1.5 billion.

By Nancy Dahlberg / ndahlberg@miamiherald.com

MoneybagMDLIVE, with more than 200 employees, provides access to virtual doctor visits utilizing partnerships with established industry leaders, including Walgreens, Microsoft and major health systems across the country. The company raised $50 million from Bedford Funding Capital Management, a private equity firm based in White Plains, N.Y. “We view this as an important first investment in a growing partnership with MDLIVE to fundamentally change healthcare in the United States,” said Charles Jones, managing partner of Bedford.

In total, South Florida companies raised more than $86 million in the second quarter, and all of that money flowed into health-tech or biotech companies. That’s up from $70.9 million last quarter, according to the report from PricewaterhouseCoopers and the National Venture Capital Association, based on data provided by Thomson Reuters.

More than half the state’s funding flowed to South Florida. The other funded companies were: CareCloud of Miami ($15.3 million), TissueTech of Doral ($15 million), Altor BioScience of Miramar ($10.7 million) and Watermark Medical of West Palm Beach ($5 million). In addition, Carson Life and Meetoou, both of Miami, raised undisclosed seed rounds.

Florida companies in total raised $153.7 million in 17 deals, up sharply from $85.6 million in the first quarter and $117.4 million in 13 deals a year ago.

Still, for the country’s third-largest state, that is less than 1 percent of the national venture capital pie.

Nationally, venture capitalists invested $17.5 billion in 1,189 deals in the second quarter, the MoneyTree Report showed. Quarterly venture capital investment increased 30 percent in terms of dollars and 13 percent in the number of deals, compared with the first quarter when $13.5 billion was invested in 1,048 deals.

The second quarter is the sixth consecutive quarter of more than $10 billion of venture capital invested in a single quarter.

“There is no reason for this to slow down. We are seeing faster growth rates in software companies than we have ever seen … and there is still a lot of room to innovate,” said Tomasz  Tunguz, partner at Redpoint Ventures in Menlo Park.

Indeed, the software industry continued to receive the highest level of funding of all industries, increasing 30 percent from the prior quarter to $7.3 billion, the largest quarterly investment total going into software companies since the inception of the MoneyTree Report in 1995.

Tunguz sees continued opportunity in enterprise software. It’s one of the fastest-growing categories in tech, yet funding is still only at half the level of 2000, he said. “There is $1.2 trillion in market cap committed to enterprise and only 2 percent of that has moved to the cloud. There is a lot of money still to change hands.”

Other categories doing well nationally were media/entertainment, with $2.7 billion going into 118 deals, and biotechnology, with $2.3 billion going into 126 deals.

The top five deals, according to MoneyTree, were AirBnB ($1.5 billion); Snapchat ($538 million), Zenefits ($500 million), WeWork ($400 million) and Docusign ($278 million).

“We saw 26 megadeals [of $100 million or greater] in Q2, including yet another billion-dollar investment. After seeing the very first billion-dollar VC investment in Q1 of last year, we now count four of the last five quarters with companies receiving billion-dollar investments, adding to the ever-growing herd of unicorns, which is approaching triple digits,” said Tom Ciccolella, U.S. Venture Capital Leader at PwC. He believes 2015 VC is on track to exceed the $50 billion invested in 2014.

Investment in Florida companies in 2015 will have a tough climb to exceed 2014, as much of last year’s $865 million total was raised by one company — Dania Beach-based Magic Leap, which raised $592 million in two rounds. But so far, South Florida healthcare-related companies are leading the charge this year. OrthoSensor, Pure Life Renal, Brickell Biotech, Vigilant BioSciences and USARAD all attracted funding in the first quarter.

MoneyTree Report results are available at nvca.org.

Follow Nancy Dahlberg on Twitter @ndahlberg.


June 22, 2015

Funding news: TissueTech raises $15 million

Miami-based TissueTech, a biotech company that focuses on regenerative medicine, raised $15 million in additional venture funding.

Ballast Point Ventures of St. Petersburg and River Cities Capital Funds in Raleigh led a Series B equity raise for TissueTech, a regenerative medicine company in Miami.

TissueTech develops regenerative amniotic tissue-based products for the ophthalmology, optometry, musculoskeletal and wound care markets. The biotech company will use the new funding to expand R&D and sales and marketing.

It’s the second time Ballast Point and River Cities have invested in TissueTech, which now has more than 100 employees, according to the Tampa Bay Business Journal. The firms invested $10 million in 2013 and have been very pleased with the company’s performance since then, Matt Rive, partner at Ballast Point, told the publication.


June 03, 2015

Startup Weekend: And the winners were ...


Startup Weekend is a non-profit, community-building event that brings together entrepreneurs of different backgrounds, including software developers, marketers, designers and startup enthusiasts. They gather to to pitch ideas, form teams and start companies in just 54 hours. The weekend culminates with demonstrations in front of an audience of judges and potential investors.

The sold-out Startup Weekend Diversity Miami, organized by Paula Celestino and her team, took place last weekend at Venture Hive. Seven teams made it to the end and presented five minute pitches in front of judges with a couple of minutes of Q&A. And the winners were ...


People's Choice winner (pictured below): PaySlay, an app aiming to slash medical bill costs through incentivizing policy holders to use gym memberships, weight-loss programs and various alternative medicine treatments. 



3rd Place (pictured below) went to Team Model Book, an app to connect models  with modeling opportunities with trade shows and events.


2nd Place went to HandyCab (pictured below), a way to ease the task of finding cabs and other transportation equipped for the disabled.


And the winner was Breakin' Bread, an app to bring people together at shared tables for communal dining experiences. Never eat alone again!


Congratulations! Please see the next post -- a guest post from the winning team.  



May 04, 2015

eMerge Americas: Martine Rothblatt looks into future of healthcare


Martine Rothblatt, founder of Sirius Satellite Radio and biotechnology company United Therapeutics, transported the audience to the future of healthcare with her keynote address, covering topics as obscure as pig organ transplants. 

Rothblatt said the end of the decade will see a strong step toward creating an unlimited supply of transplantable organs.

"We now are in a partnership with several companies to develop a genetically modified pig whose lungs will not be rejected when they are transplanted into the human body," Rothblatt said. 

She said she expects her company, with the added push of competition from other companies studying similar transplant opportunities, will be able to transplant a genetically modified pig lung into a human body by the end of the decade.

And after pig lungs, what's next? Stem cells, Rothblatt said. 

2030 will see the use of stem cells to create organs such as hearts and livers, saving lives and billions of dollars annually in hospital bills.

-        Chabeli Herrera

April 17, 2015

MoneyTree Report: Healthcare attracts most of South Florida's VC funding

MoneyIn the first quarter, South Florida companies attracted 79 percent of Florida's $89.7 million share of venture capital investment. Investments in YellowPepper, OrthoSensor and Pure Life Renal led the pack. But Florida companies still draw only a tiny sliver of the national venture capital pie.

By Nancy Dahlberg / ndahlberg@miamiherald.com

South Florida companies reeled in the lion’s share of the state’s venture capital financing in the first quarter, and most of the investments were in healthcare-related companies.

Venture capitalists invested $89.7 million in Florida-based companies, and $70.9 million of that fueled companies based in Miami-Dade, Broward and Palm Beach counties, according to the MoneyTree Report from PricewaterhouseCoopers and the National Venture Capital Association released Friday.

The biggest financing rounds went to YellowPepper of Miami, a fast-growing mobile banking and payment network for Latin America that raised $19 million, OrthoSensor of Dania Beach, a maker of smart orthopedic devices, also with $19 million, and Pure Life Renal of Hollywood, a dialysis company that raised $10.5 million, according to the report.

Healthcare companies, including biotech, medical devices and medical technology services, grabbed $45.2 million in South Florida. In addition to OrthoSensor and Pure Life Renal, other investments included $7.3 million in Brickell Biotech, an early-stage biotech company focusing on skin diseases; $5 million in Vigilant BioSciences of Miami, a company developing a test for oral cancer risk, and $3 million in USARAD of Fort Lauderdale, an early-stage medical device maker.

Interest in the life sciences is on the uptick and a national trend, said Bruce Booth, partner in Atlas Venture, which specializes in early-stage biotech and last year seeded a company out of Scripps Research Institute called Padlock Therapeutics. Booth has been seeing a big increase in platform companies and virtual biotech companies that don’t have their own labs but instead partner with research organizations around the world.

“The environment has never been as strong as it is now for putting together new companies and being able to attract financing to scale them over time,” said Booth. “We’ve had eight or nine quarters now where we have had the best IPO environment in the 40-year history of biotechnology. We also have a really strong M&A environment.”

Investors in Florida are taking notice, too. Part of OrthoSensor’s funding came from Tullis Growth Fund, part of the Tullis family of private equity funds that invest in emerging healthcare companies. Tullis, based in Connecticut, established an office in Palm Beach Gardens about five years ago.

“We are looking at more investments in Florida right now — we’re finding the opportunities here,” said Jim Tullis, the fund company’s founder, who lives in Palm Beach County. “This is a terrific area with a very promising future. The local research base coming off the universities is exceptional and probably under-recognized by venture capital at this point. … The tax situation doesn’t go unnoticed by CEOs looking for their next effort, there is an increasing talent pool available and there is good local capital in Florida in terms of angels and, increasingly, funds. It’s a nice combination of technology, people and money.”

OrthoSensor, founded in 2008, has already raised about $53 million in financing, bringing its total funding to about $72 million.

Vigilant BioSciences’ financing included investments by venVelo, based in Central Florida, and the Florida Institute for the Commercialization of Public Research, which provides seed funding and support to early-stage companies commercializing university technology, as well as a group of private and angel investors committed to the life sciences.

Of the 19 investments of the New World Angels, one of South Florida’s well-established angel groups, more than a third are in healthcare-related industries. And in a recent interview, John Sculley, the former Apple CEO who is now an angel investor and startup mentor in Palm Beach County, said he sees healthcare and specifically health-tech startups as a huge opportunity for the tri-county area and the state: “Healthcare is a $3 trillion annual spend, it’s incredibly inefficient, its rules are fought by special interest groups and there is a legacy of incumbent large customers and government institutions that don’t change quickly.”

To be sure, Florida grabbed only a teeny slice of the national venture capital pie — two-thirds of 1 percent — in all industries. Even though Florida is the third largest state by population, it was No. 28 in the first quarter for venture investments, according to MoneyTree’s data. Florida’s total of $89.7 million in 14 deals is down from $129.6 million in 19 deals in the first quarter of last year and way down from last quarter’s $581.2 million, which included the $542 million Google-led investment in Magic Leap.

Nationally and in all industries, venture capitalists invested $13.4 billion in 1,020 deals in the first quarter of 2015, according to the MoneyTree Report, based on data provided by Thomson Reuters. Quarterly VC investment declined 10 percent in terms of dollars and 8 percent in the number of deals, compared to the fourth quarter when $14.9 billion was invested in 1,103 deals. However, the first quarter is the fifth consecutive quarter of more than $10 billion of venture capital invested in a single quarter.

Ride-sharing company Uber and highflying SpaceX drew the highest investments — $1 billion each — while Lyft was No. 3, receiving with $530 million.

Nationally, the software industry continued to receive the highest level of funding — $5.6 billion — of all industries, despite being down for the quarter. The biotechnology industry captured the second largest total during the quarter with $1.7 billion. Overall, first-quarter investments in the life sciences sector (biotechnology and medical devices combined) received $2.2 billion going into 193 deals nationwide, including nine in Florida.

MoneyTree Report results are available at www.pwcmoneytree.com and www.nvca.org.

Follow Nancy Dahlberg on Twitter @ndahlberg.

Top deals

In South Florida, these were the top deals in the first quarter, according to the MoneyTree Report.

YellowPepper: $19 million

OrthoSensor: $19 million

Pure Life Renal: $10.5 million

Brickell Biotech: $7.3 million

VirtualWorks: $6.7 million

Vigilant BioSciences: $5 million

USARAD: $3 million

AviseNA: $517,000


February 25, 2015

Miami life science startup attracts $5.5 million in funding for oral cancer system


Matthew H.J. Kim, who founded Vigilant Biosciences, and serves as the company’s chairman and CEO, is shown with Dr. Elizabeth Franzmann, who is looking at a OncAlert point-of-care test prototype. Vigilant is working on an early detection system for risk of oral cancer. PATRICK FARRELL MIAMI HERALD STAFF

By Nancy Dahlberg / ndahlberg@miamiherald.com

Matthew H.J. Kim, a patent attorney by training, was heart-broken seeing the the suffering and aggressive treatment his mother went through with oral cancer. He also saw first-hand the results of what he calls an inadequate standard of care resulting in most cancers of the mouth not being detected until stage three or four. A mortality rate as high as 50 percent could be cut way back with early detection, he believed.

“I felt helpless and wanted to do more. ... You are fighting great odds by the time you get to that stage,” said Kim, explaining his mother had to lose a portion of her jawbone as part of her treatment.

More than four years ago, Kim began researching technologies in development and found one at the University of Miami. After more research and talking to the scientists there, he began negotiating the license. “In homage to my mother, I executed the license on Mother’s Day of 2011,” he said, and Miami-based Vigilant Biosciences was born.

Since then Vigilant’s products — a point-of-care oral rinse test and a more quantitative lab test that can aid in early detection of risk for oral cancer — have been in development and have passed one of the key regulatory hurdles toward commercialization in Europe. On Tuesday, the company announced it has completed its Series B round of funding, which will pay for commercialization in Europe and the start of the regulatory process in the U.S. this year.

The company’s $5.5 million investment round brings the total amount raised to date to $7.8 million. The financing includes investments by White Owl Capital Partners, venVelo, the Florida Institute for the Commercialization of Public Research and several existing investors, as well as a group of private and angel investors committed to the life sciences.

Specifically, Vigilant will use the funds to drive toward CE Mark approval in Europe and U.S. regulatory approval for its OncAlert Oral Cancer Risk Assessment System. The funds raised will support the international product launch and commercialization of the OncAlert System as well as other products in Vigilant’s pipeline.

“As hundreds of thousands continue to be diagnosed with oral cancer every year, we are committed to providing an accurate, effective and affordable way to aid in the early detection of risk for the disease. This funding will enable us to address this critical market need that has gone unmet for far too long,” said Kim, who founded two other companies and developed a number of medical screening and monitoring systems.

Vigilant’s OncAlert Oral Cancer Risk Assessment System is based on patented technology that detects specific protein markers known to indicate an elevated risk for oral cancer, even prior to the observation of visual or physical symptoms. The simple, oral rinse procedure is easy to administer during a dental checkup and non-invasive for the patient, the company said. Both the rapid point-of-care test and the more extensive lab assay that comprise the OncAlert Oral Cancer Risk Assessment System could be on the market in Europe by mid-year. 

“Together, it will be a very effective early detection system for the risk of oral cancer. Our test is a very simple and elegant solution that can be easily integrated into the standard of care,” said Kim. While his mother is now five years cancer free, others aren’t so lucky. “We are now focused on oral cancer but we believe the technology has promise for other cancers,” said Kim.

According to the World Health Organization, there are more than 600,000 new cases of head and neck cancer and 300,000 deaths each year worldwide. Currently, the vast majority of patients are detected through a visual exam and/or are symptomatic, at which point they are likely late stage. As a result, oral cancer often goes undetected to the point of metastasizing. Early diagnosis of oral cancer results in a cure rate of up to 90 percent, the company said.

Dr. Elizabeth Franzmann, an associate professor of otolaryngology at the University of Miami’s Sylvester Comprehensive Cancer Center, is scientific founder and chief scientific officer of Vigilant. Her clinical research on selective salivary biomarkers for head and neck squamous cell carcinoma serves as the foundation for the company’s initial product. The company last week added a vice president of global sales and marketing to the team.

Vigilant, now a team of 10, received support and mentorship from the U Innovation team, led by Norma Kenyon, chief innovation officer at the UM Miller School of Medicine. U Innovation also connected Vigilant with the Florida Institute for the Commercialization of Public Research, which provided the company’s initial seed funding of $300,000 that served as a catalyst to attract more seed capital.

The Institute invested another $200,000 in the Series B round, and like U Innovation, it helped with introductions and access to resources, Kim said.

“Matthew started the company to address the lack of good diagnostics for oral cancer, a disease that both of his parents suffered from,” said Jane Teague, chief operating officer of the Institute. “Vigilant exemplifies what programs like ours are all about, providing seed funding to early-stage companies to bridge the gap until they qualify for and can attract later-stage financing.”

Follow Nancy Dahlberg on Twitter @ndahlberg.

Read more here: http://www.miamiherald.com/news/business/article11095052.html#storylink=cpy

February 24, 2015

Magic Leap's Rony Abovitz on starting a company: Don't do it if it's not rocking, if it's not awesome


By Nancy Dahlberg / ndahlberg@miamiherald.com 

Rony Abovitz, CEO of the mysterious Magic Leap startup, returned to his alma mater, the University of Miami, to share some secrets of entrepreneurial  success -- and just a very few snippets about the company he is currently building.

"There's a whole mystery to what Magic Leap does and I hope half the room isn't here to find that out because I am not really going to unveil it," he told the group of about 250 gathered at the UM Newman Alumni Center for the College of Engineering's Entrepreneurship Forum, part of its Engineering Week events. Instead he talked about pivotal moments in his career of starting companies, including a couple that will no doubt become part of Magic Leap lore, and what he has learned about being a leader.

Magic Leap, founded in 2011 and  based in Dania Beach, is developing "Cinematic Reality" backed with an eye-popping $542 million  from Google and venture capitalists, the third largest fund-raising round of the year last year. "I still go holy crap, I still can't really believe it," he said of the round. The company is now valued at about $2 billion. 

One of the first articles that have begun to explain the technology was published this month in the MIT Technology Review. Said the writer, Rachel Metz, who tried an early prototype of the technology: "It’s safe to say Magic Leap has a tiny projector that shines light onto a transparent lens, which deflects the light onto the retina. That pattern of light blends in so well with the light you’re receiving from the real world that to your visual cortex, artificial objects are nearly indistinguishable from actual objects."

Metz said the company is aiming to fit its technology into a "glasses-like wearable device" and that, according to Abovitz, the technology  "is not far away." He may share a few more details with the world today: Abovitz is hosting a Reddit AMA (Ask Me Anything) at 2 p.m. EST.   (Update: read it here)

The fast-growing Magic Leap is approaching "a few hundred" employees spread between Dania and Mountain View, Calif., as well as New Zealand and London, Abovitz said in a short interview before the UM talk. Abovitz said he would like to base 80 percent of the company in South Florida.

He also said in the interview he wants to help South Florida grow a technology community and would like to see UM become a Stanford of the South. Abovitz earned his engineering bachelor's and master's degrees at UM in the mid-90s and was in one of the university's first biomedical engineering programs, which he credits with stirring his interest in developing technology for the human body. Before starting Magic Leap, Abovitz was co-founder of Mako Surgical, the South Florida medical robotics company that sold for $1.65 billion to Stryker in 2013.

Abovitz believes in the next five years augmented reality technology will become widely adopted. But what sets  Magic Leap apart from its competitors is how it works with the body rather than against it, he said before the talk. "No one else is doing that.... Put the body first and engineer around it... All computing will be biomedical going forward."

 In the talk at UM, Abovitz shared some of the defining moments of his career. For instance, one day after receiving good news about funding for the robotics company, Sept. 11, 2001 happened. Another one: Going public in 2008.

During both times, the world was ending but the team kept going. In 2001, after his investors pulled out, that meant taking a van around the country, prototype robot in the back, and not coming back until the company secured funding. In 2008, Mako was known as that crazy team trying to go public during the Great Recession.  These are the times you learn what you are made of, he said.

But these defining moments also included the first time a Mako robot was used in a surgery on a human.  "That was one of the greatest moments of my life," he said of the successful surgery in a Fort Lauderdale hospital in 2006.

There have already been a few pivotal moments in the Magic Leap story, too. Abovitz said a trip with music industry mogul Chris Blackwell to Blackwell’s GoldenEye resort in Jamaica in 2011 helped to ferment Abovitz’s idea for Magic Leap. He loved being out in the environment, not staring into the phone, and realized computing had to change. “That’s where the world becomes your new desktop. … We shouldn’t bend to technology, technology should bend to us.”

 Four days after Magic Leap received the "serious capital" from Google and other investors,  Google executive Alan Eustace parachuted a record-setting 135,000+ feet from a balloon near the top of the stratosphere. Eustace had spent time in Magic Leap in May, and was one of the engineers who pushed for the funding. That was a message too: "For cool things to happen, you have to get out of your comfort zone," said Abovitz, who  took up his own challenge of becoming a javelin thrower on the UM team during his college years.

"When you are doing something neat and you’re doing it with neat people and there is that convergence, something amazing will happen," he said. "If you really want to change the world, you have to have that attitude."

On leadership, he told the engineering students and alumni, you have to be bold. "It's little like jumping off a cliff with your backpack, a bag of parts and you are building the plane wings and engine  on your way down.... You also have to be insanely tough, you'll get pummeled over and over again and you have to keep getting back up. ... And you have to attract a team that is freaking smart."

Creativity and finding a counter-balance play a big role too -- it's why he was a cartoonist for the school newspaper during his UM years and now plays in a band, Sparkydog & Friends. But he told the students the most important thing to learn is teamwork. "Starting a company is like doing 100 Iron Mans [competitions] in a row," he said. And while it requires endurance and mental toughness, have fun. "Don't do it if it is not rocking, if it's not awesome."

And don't take yourself too seriously, said Abovitz, who once gave a TED talk dressed as an astronaut.

Posted Feb. 24, 2015 

January 19, 2015

Q&A: Healthcare ventures ‘a work of love with a mission to cure’

Carmen I. Bigles, who studied architecture, has been busy building healthcare companies, including Coquí Radiopharmaceuticals. She says she couldn’t do it without ‘Team Bigles-Serrano.’

By Nancy Dahlberg / ndahlberg@miamiherald.com

BMQACarmen0100 Bigles MSHWith her two daughters playing and singing together at a desk off to the side, Carmen I. Bigles explains what motivates her to juggle two large healthcare ventures at the same time.

“The reason I do it is right over there — those two little girls,” Bigles said in her makeshift office in a construction trailer as workers were building the Caribbean Radiation Oncology Center in Doral.

She has co-founded the center for advanced oncological radiation technology with her husband and “best friend,” Dr. Pedro A. Serrano-Ojeda, a radiation oncologist. The state-of-the-art Doral center, set to open in the second quarter of this year, is the second center; the first site opened in Bayamón, Puerto Rico in 2007. “It’s a work of love with a mission to cure,” she said.

With a growing company to run, her husband practicing medicine half the week at their clinic in Puerto Rico, and an 8- and 10-year-old to raise, Bigles doesn’t need another challenge. But in 2009, a big one came onto her radar.

Mo-99 is the parent isotope of Technetium-99, which is used in 80 percent of nuclear medicine procedures worldwide. Globally, only a small number of facilities have the capacity for the commercial production of radioisotopes. Yet the U.S., the largest market for medical radioisotopes, has no domestic supply and in turn relies on imports from Europe and elsewhere.

Essential to nuclear medicine, radioisotopes are applied in the diagnosis and treatment of diseases of the brain, heart, lung, liver, among many others. Having a half-life of only 66 hours after production, Mo-99 cannot be stockpiled and presents unique distribution challenges when imported into the U.S. In recent years, Mo-99 shortages deprived patients of lifesaving diagnostics and treatment. And time is of the essence: Many reactors around the world are aging and set to go offline by 2016.

Still, there are only 24 hours in a day — Bigles wasn’t convinced she was the one to take this on until team and family members urged her on.

“We went to our daughter’s school, and my husband grabs me by my hands, and says ‘you know, uranium. That’s what people are fighting over getting to make weapons. A superhero would be really good right now to save this. If you brought this to the States, you would be creating manufacturing jobs in the U.S and you would help stop the proliferation of weapons-grade uranium and the future of those two little girls would be saved.’ I cried, dried my tears went inside and said ‘let me think about it.’ Then I said, ‘let’s do it.’ ” Bigles recalled.

So Bigles started Coquí Radiopharmaceuticals, with the mission of establishing a domestic source of Mo-99 by 2020 or sooner. The regulatory hurdles are high, as are the financing requirements — the overall cost of the project is in the $330 million range and Coquí is financing it in stages, she said.

Coquí just signed a contract with INVAP [an Argentinian nuclear engineering firm] to design Coqui’s Medical Isotope Production Facility in Alachua on land gifted by the University of Florida Foundation. Coquí is beginning the licensing application for the Nuclear Regulatory Commission and the construction plans for local regulators. At any given time there are about 200 people involved in Coquí, she said.

In that trailer she shared the triumphs and struggles of her entrepreneurial journey, which she said would only be possible because she is part of “Team Bigles-Serrano.” The Miami Herald followed up with additional questions by email.

Q. What was you and your husband’s biggest challenge developing the first Caribbean Radiation Oncology Center and what did you learn for your second center now under construction?

A. There were many challenges and we risked everything financially. The bank basically had everything we owned for collateral. In that situation, you either sink or swim. I am happy to say we became gold medalist swimmers.

Q. How did co-founding Caribbean Radiation Oncology Center in Puerto Rico prepare you for your current endeavor with Coquí?

A. The principles employed for the Caribbean Radiation Oncology Center — perseverance, organization, sacrifice, faith and empathy for patients and their families — all apply for Coquí as well. The success of the oncology center gave me the heart to continue to seek endeavors to assist people that are in the battle for their lives. It also gave us an understanding as to the importance of nuclear medicine. Patients need the precious, scarce medical isotope (Technetium-99m, the daughter of Molybdenum-99) for diagnostics as do scientists and doctors who are arduously working on treating and finding cures to Parkinson’s disease, Alzheimer’s disease, cancer and cardiac diseases, among others.

Q. What is Molybdenum-99?

A. Mo-99 is the parent isotope of Technetium-99m, which is used in 80 percent of nuclear medicine procedures worldwide. Technetium-99m is used in approximately 50,000 medical diagnostic procedures each day in the U.S. However, the U.S. has no production source for Mo-99. International production facilities are old and frequently unreliable and this delays delivery.

Q. What would happen if the U.S. is not in control of its own supply of radioisotopes?

A. In 2012, Congress passed legislation making it a national priority to produce Mo-99. When the Canadian reactor goes offline (expected 2016) there will be no major reactor this side of the hemisphere that can supply substantial amounts of Mo-99. The scenario is gearing up for supply shortages and the price is more than likely going to increase significantly due to the fact that current suppliers may need to rent more time in existing reactors for the fission production of the isotope.

Q. Why did you name your company Coquí?

A. Coquí is the common name for a small frog endemic to Puerto Rico. They are onomatopoeically named for the very loud mating call the males make at night. I believe they are the loudest amphibian. I am Puerto Rican and just like the Coquí, our company started small but we look to be very loud in our industry.

Q. There is certainly a long regulatory and licensing process, not to mention a capital intensive one, involved with developing Coquí. Was there ever a time you thought about giving up?

A. I have to confess, yes, but I persevere. I believe that when Coquí is operative what we produce will save lives, so that certainly keeps me going. We have a spectacular team of individuals helping us through this process — INVAP, MPR Associates, Gresham, Smith & Partners, Hogan Lovells, ENERCON, CHW and the University of Florida, among others — and to that end I am truly inspired to see this through.

Q. I am sure you have faced a number of naysayers. What keeps you going?

A. I have unshakable faith in Coquí. I know from the bottom of my heart that I will leave this legacy for future generations. We are making history and those naysayers have only encouraged me to go further, to be louder, and to say that with my team we will make Coquí thrive. We work so hard because the U.S. patients need this product and the world needs non-proliferation of nuclear weapons.

Q. How do you balance raising two young girls, helping to run the construction of the second Caribbean Radiation Oncology Center underway in Doral and running Coquí all at the same time?

A. I belong to another team, the Serrano-Bigles team. This team is comprised of my husband and best friend, Dr. Pedro A. Serrano, my two daughters Carmen Irene and Caterina Isabel and yours truly. The girls travel with me to meetings around the world and they are humble, very well behaved, have empathy and are of pure heart. I am very organized, I listen well, I ask questions, I do not do well with drama and I do not like to waste time.

Q. What stage are you at with Coquí?

A. We recently signed the official land transfer declaration with the University of Florida Foundation for the 25-acre parcel in Alachua County which Coquí will call home. We are currently in the licensing process and the environmental report is 85 percent complete. Much time and work goes into the environmental report and licensing. For example, the migrations of birds on the site had to be evaluated for 12 months. The licensing application is about 40 percent complete and we are on schedule to submit our application to the Nuclear Regulatory Commission by the last quarter of this year.

Q. Tell me a little about your board of directors.

A. Luis Reyes sits on the board and has more than 35 years of nuclear experience and has served in various Nuclear Regulatory Commission senior management positions. Most recently appointed to the board is Ian Turner, the former head of the radiopharmaceuticals business for the Australian Nuclear Science and Technology Organization (ANSTO). Michael Matte has served as the chief financial officer, executive vice president and secretary of QuePasa Corp. since 2007 and is a director of Iris International and GelTech Solutions.

And we have two prestigious radiation oncologists on our board, Dr. James Welsh and my husband, Dr. Pedro Serrano-Ojeda. Welsh is a board certified radiation oncologist and neuro-oncologist, president of ACRO (American College of Radiation Oncology) and has been a member of the Advisory Committee on the Medical Uses of Isotopes, which advises the U.S. Nuclear Regulatory Commission on medical issues, from 2007-2014. Serrano-Ojeda is a certified radiation oncologist who founded Caribbean Radiation Oncology Center Puerto Rico with me in 2007 and has a patent pending medication that will hopefully cure cancer.

Q. I know Louisiana and the world of gumbo was trying hard to lure Coquí as well as other states. Why did you decide to build in Florida on land given by the University of Florida Foundation?

A. There is a long history of the site selection process and many individuals worked to bring Coquí to Florida, including Governor Rick Scott. The research and synergy with the University of Florida, their Nuclear Engineering Department and all the local hospitals and medical research that is conducted at the university is very impressive. I am truly grateful to the University of Florida Foundation. It is as if our relationship was always meant to be.

Q. What does your architecture and urban planning — plus mathematics — background bring to the table?

A. It has been a great confluence for me. I’m able to look at all aspects of this project from the micro to the macro. It’s like viewing a movie with 3-D glasses, you have a better perspective.

Q. I imagine the world of nuclear medicine is rather male dominated. If that’s so, what’s that like for you? Do you have other women on your team?

A. Yes, it is dominated by men. I also work very closely with the government and that is also predominantly male dominated. I am not intimidated and I believe most recognize that, so for the most part, I believe it gets us past any gender issues. I do have many brilliant women in my team, but mainly as of coincidence. I also have many brilliant men that are part of the team as well.

Q. What’s the best advice you have ever received and from who?

A. It was from a man who passed away some time ago, he was a father figure for me. He said, “Always get to yes and leave your emotions on the side.” In other words, make intelligent decisions and leave your ego on the sideline.


Ventures: President and CEO of Coquí Radiopharmaceuticals, which she founded in 2009 with the goal of establishing a medical radioisotope production facility in the United States; Co-founder and former chief financial officer of Caribbean Radiation Oncology Center.

Age: 42

Family: Born in Puerto Rico, Bigles lives in Coral Gables with her husband, Dr. Pedro A. Serrano-Ojeda, and their two daughters, Carmen Irene Serrano-Bigles and Caterina Isabel Serrano-Bigles.

Education: Bachelor’s degree in mathematics from Interamerican University in San Juan; master’s degrees in architecture and suburban and town planning from the University of Miami.


Follow Nancy Dahlberg on Twitter @ndahlberg.


November 24, 2014

Startup Spotlight: Entopsis

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Headquarters: Hialeah Technology Center

Concept: Entopsis is developing an innovative molecular profiling platform that will allow people to diagnose themselves for diseases at home easily, cheaply and quickly using just a NuTec, a specialized glass slide the company developed, and an app on their smartphone. A liquid sample of blood, saliva or urine is placed on the glass slide, heated to cause changes in color and photographed with your smartphone or with a photo scanner. Then, the photo is uploaded through the corresponding app, which will deliver the diagnostic results through a cloud-based system in seconds.

Story: Entopsis founders Ian Cheong and Obdulio Piloto (pictured above)  met while obtaining their doctorates at Johns Hopkins University School of Medicine and have been friends for 12 years. Since both had scientific medical backgrounds, they knew that they wanted to work together to create a technology that would help people in a significant way. Many people in developing countries lack access to life-saving diagnostic tests, mostly due to their high cost, invasiveness and the countries’ lack of advanced medical infrastructure, so Cheong and Piloto set out to create a diagnostic platform to tackle that problem.

Ens00 Entopsis BIZ PPPThis is a testing technology that can be applied to almost any substance and across a range of industries such as food science, with food contamination and agriculture, with disease detection in livestock and for people to be tested for various diseases. Entopsis is the only company in Florida supported by the competitive Peter Thiel Foundation’s Breakout Labs.

Launched: January 2012

Management team: Obdulio Piloto, Ph.D., co-founder and CEO; Ian Cheong, Ph.D., co-founder; George Huang, Ph.D., CFA, chief financial officer; Tingjun Lei, Ph.D., lead scientist (pictured below).

No. of employees: six

Website: www.entopsis.com

Financing: “We have invested $500,000 in the business to date, including self-funding, gifts and funding from Breakout Labs and other investors for the research and development phase,” Piloto said.

Recent milestones: Entopsis has significantly improved the capabilities of its novel machine-learning system, a process that took about five months. This breakthrough in technology now allows for a quicker and more accurate diagnosis, improving the overall product. In addition, their team has also made numerous improvements to the molecular binding surfaces on the NuTec, thus allowing for the capture and visualization of even more diverse biomarkers. Entopsis also just recently expanded manufacturing and laboratory space at the Hialeah Technology Center, allowing the company to run more tests on a variety of sample types without risk of cross contamination.

Biggest startup challenge: Funding and access to patient samples. “In order to test our platform across multiple industries, we need to partner with different beta testers in each field, such as the food industry, diagnostics, and bio defense, in order to identify problems and how NuTec can potentially solve them,” Piloto said. The company can develop a new diagnostic test in less than a week: “The challenge we are encountering is gaining access to patient samples so that we can fully demonstrate the advantages of our technology.”

Next step: Finalizing the NuTec platform and developing tests for commercial use. “Right now, we have many different prototypes, so we want to take the best aspects of all prototypes and turn them into one platform to commercialize for public use, while making the testing as automated as possible,” Piloto said. “Once complete, we will offer the platform to beta-testers and further optimize before offering the platform to the consumer market. We are always looking for partners interested in co-developing tests with our team.”

Investor/mentor's view: “Breakout Labs looks for novel cutting-edge science with broad application. Entopsis is based on an entirely new way to analyze biomolecules that, if successful, could become the new paradigm for rapid molecular identification in contexts ranging from food safety to medicine,” said Lindy Fishburne, executive director of Breakout Labs, adding that Entopsis has faced and overcome a number of development challenges.

“Because we fund many platform technologies, we see that our companies very often face a theoretical embarrassment of riches in choosing the right first application. The advice we give them is to go out and talk early and often with the potential customer to understand the pain points that the technology can solve and where the practical challenges would be in its integration into existing workflows or pipelines,” Fishburne said.


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 Photos by Pedro Portal / El Nuevo Herald

Posted Nov. 24, 2014