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IlluminOss Presents Novel Approach to Fracture Fixation

Bone Zone IlluminOss

April 9, 2014

PDT MachineWith recent expansion in European countries and a plan for a clinical trial in the U.S., IlluminOss Medical is beginning to develop clinical and economic data showing the benefits of its patient-customized fracture implant, the Photodynamic Bone Stabilization System (PBSS).

Implanted in about 400 patients to date, the PBSS is a deviation from traditional hardware used in fracture fixation technologies. A balloon is inserted into the bone canal, then a liquid monomer is inserted into the balloon and hardened with a light source to form an implant. The implant shapes to the bone canal and requires no direct bonding. Patients have near-immediate rotation stability.

BONEZONE spoke with Dirk Kuyper, Chief Executive Officer of IlluminOss Medical, about the fracture repair technology and the company’s plan to gain market share.

BONEZONE: Could you describe how the Photodynamic Bone Stabilization System works?
Dirk Kuyper: It’s a concept that takes a balloon similar to an angioplasty balloon made out of Dacron, which has been used in sutures and other medical products for 40 or so years, combines it with a liquid monomer that is similar to what has been used in dentistry for bonding teeth for about 50 years, and combines these to make a customized intramedullary implant for fractures or impending fractures.

The surgeon makes a small, (about 6.5 millimeter) incision to gain access into the bone, cleans out the canal, inserts the balloon across the fracture and fills it with the liquid. Then, it is hardened with a very specific visible light wave. What you get is a customized, immediately stable implant.

BONEZONE: What problem does this implant solve?
Kuyper: If you look at the implants that are popular today across fracture treatment, there’s casting, which debilitates a person for a long period of time and isn’t always successful. There’s plating, which really hasn’t evolved much. Then there are intramedullary nails, which have been around since the late '40s and early '50s, which haven’t changed a tremendous amount. None of those products were developed for patients with osteoporosis or metastatic bone disease. All of those products are designed for healthy bones that are easy to screw into, that are strong and that heal quickly. Our implant specifically addresses poor bone quality and provides a more minimally invasive and better fixation than you have when you’re dealing with bad bone quality.

BONEZONE: For what applications is this currently being used?
Kuyper: We have approval in Europe for low- to non-low bearing bones: the radius, ulna, fibula, distal radius—there are a number of bones for which we have a CE Mark. It’s being used extensively in wrist fractures, especially in elderly patients.

What’s amazing is that we’re seeing these patients go home in one day vs. four or five days if they had a volar plate, with one week of rehab instead of six. If an elderly person loses the use of her hand for five or six weeks, that has a pretty serious impact on her quality of life. The ability to get patients back using their hands almost immediately and to be self-sufficient is a huge improvement in terms of treatment. Our goal is to change the way surgeons and healthcare systems think about treating older patients with fractures, change the paradigm of treatment. The whole goal is get them back to their normal daily routine as quickly as possible. We do that substantially faster than traditional fixation methods.

BONEZONE: The cost of new and novel implants is a continual concern for healthcare systems in the U.S. and Europe. How are you addressing these concerns?
Kuyper: We’re doing an economic study on how much money the product saves. In the Netherlands, for instance, patients are going from about four or five days in the hospital to one day, six weeks of rehab down to one week; patients are regaining total mobility quickly. There is a significant cost savings both to the healthcare system and to the caregivers. We’re quantifying that, and will use that to justify the cost of our implant.

BONEZONE: What are your plans for product expansion?
Kuyper: In the short term, we’re not planning to expand much beyond where we are. The reasoning for that is we’re going to run two clinical trials, one in the U.S. and one in Europe, to get the rest of the bones, the weight bearing bones, femur, tibia and humerus approved for the indication, as well as develop the economic healthcare data I was talking about. Our plan over the next 18 months is to grow the user base, grow the clinical data, develop and publish economic data and then look to expand in 18 to 24 months.

BONEZONE: Based upon our knowledge of the market, this seems to be a novel technology. What competition do you have?
Kuyper: We’re extremely well-protected from an IP standpoint, so it would be difficult for somebody to come in and try to do what we’re doing. It’s really one of the first new fixations in fracture technology in the last 40 years. In terms of new competition, no, especially when we look at our potential target market segment of osteoporosis and metastatic bone disease. It’s such an improvement over the current treatment option that we really don’t see a lot of competition.

Dirk Kuyper has over 25 years of experience in commercializing medical devices. Prior to joining IlluminOss as CEO, Mr. Kuyper was President and CEO of Alphatec Spine,, where he led the company to triple revenue to $200 million and expanded the brand globally into 52 markets. Prior to Alphatec, as President of Aesculap, he successfully launched spinal and orthopaedic divisions. Questions may be sent to info@illuminoss.com.

PR Week Showcases LaVoieHealthScience's Work with Department of Public Health

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Check out PR Week's article on LaVoieHealthScience's Work on the Massachusetts Department of Public Health's Emergency Preparedness Month.

Local Drug Developer Touts Survey Showing Patients Would Adhere Better to its Drug

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March 25, 2014

Jason deBruyn

Raleigh oncology medication company Dara BioSciences is touting a survey that shows patients with breast cancer would be more likely to properly adhere to their medication if it came in a drinkable liquid, something only Dara sells.

Drug adherence among women taking the breast cancer drug tamoxifen is not very good, with as many as 50 percent of patients discontinuing treatment earlier than they should, according to Dara (Nasdaq: DARA). In the recent survey, led by Dr. Stefan Glück of the University of Miami, 14 percent of the 626 patients involved in the survey self-reported that they miss two or more tamoxifen tablet doses each month.

In addition, 8 percent identified swallowing difficulties with the tablet, and 7 percent said a liquid form would help them achieve long-term compliance.

Naturally, as the only company to sell a liquid form of tamoxifen, under the brand Soltamox, Dara CEO Dr. David Drutz liked the results of the survey, which was titled CAPTURE (Compliance and Preference for Tamoxifen Registry).

“We have achieved this goal and are confident that CAPTURE’s key findings will provide invaluable information to the oncology community to help advance clinical practice and improve adherence to tamoxifen therapy,” he said. "Sub-optimal adherence remains an important challenge for many physicians and patients, and providing therapeutic options to patients may be an important tool to encourage patients to take an active role in their long-term treatment.”
In the United States, more than 230,000 new cases of breast cancer are diagnosed each year, and more than 1.8 million prescriptions are written for tamoxifen, according to Dara.


Donna LaVoie to Speak at "How to Prepare for the IPO" on March 14

describe the imageProgram Overview

There's no denying the recent surge in IPOs for life science and med-tech companies with 51 in 2013 and early reports say there are already a number in the queue for 2014. This session will review key components in the legal, marketing and finance areas that should be considered by companies before commencing the process of going public. Join us for an in-depth session on planning a path to IPO and we hope you walk away with the real story behind how things work so you can make it happen for yourself.

Key topics:

  • Requirements of the SEC
  • At what stage should a company consider the public market
  • The importance of building the right company profile and team
  • Variable costs associated with being a public company
  • Life after going public

The "How to... Workshop" series is dedicated to giving you the keys to a successful business, from creation to exit. As with all our events, the "How to... Workshop" is interactive and informal so bring your questions with you!

   

Speakers

Donna LaVoie | CEO & Founder, LaVoie Strategic Communications Group
Megan Gates | Member, Mintz Levin
Christine Gallagher | Managing Director, Equity Capital Markets, SunTrust Robinson Humphrey 

Who Should Attend

Senior management and board members of emerging growth companies in the life science and med-tech industries

Agenda

11:30 AM | Registration, Lunch, and Networking
12:00 PM | Welcome, Presentation & Q&A
1:30 PM | Program Close

Fees

Academic/Student Rate | $20
General Public | $35

Location

LabCentral
700 Main Street
Cambridge, MA 02139

Dara's Victory Could Garner Attention from Big Pharma

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February 26, 2014

Jason deBruyn

When Dara BioSciences received the“orphan drug” designation Tuesday, it was as though the dealer stocked their bargaining kitty with a fresh stack of strong chips.

The U.S. Food and Drug Administration reviews drugs before companies may sell them. In certain cases, it awards a potential new drug the orphan drug designation, meaning that drug would treat a disease found in fewer than 200,000 people.

This is huge for Dara (Nasdaq: DARA) because it means this drug will have seven years of market exclusivity, a very strong bargaining chip when discussing a deal with potential partners.

Big Pharma likes owning orphan drugs because no other company may compete for those exact patients. Without competition, companies can keep prices high. In some cases, the price of a drug can drop as much as 90 percent after patent expirations.

Small companies like Dara typically work on potential new drugs in smaller trials, but can’t afford larger studies or later development because costs can run into the hundreds of millions. So, they often will look to partner with a larger drug company. In those deals, the large company takes on responsibility of developing, testing and filing a new drug application with the FDA, but agrees to pay the small company certain milestones and royalties if that drug reaches the market.

The orphan drug designation not only makes the Dara product more appealing for a deal in the first place, but when big drug companies compete against each other for a deal, it can mean higher milestone or royalty payments for Dara.

“For U.S. partners, this creates a lot of interest,” says Dara CEO Dr. David Drutz. “Some have told us they might be particularly interested if we get the (orphan drug) designation.”

The drug doesn’t have a name yet, and is simply titled KRN5500. Some studies on the drug have shown that it reduces nerve pain in patients undergoing chemotherapy, something for which there is not good treatment currently available, and for which traditional pain medication does not seem to work.

LaVoie Group Announces New Location

LaVoieHealthScienceLogo
Our focus has not changed, but our new location and logo will...

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Building Value for Health Science Innovations
Please be sure to note our new location and update your records to:
One Thompson Square, Suite 503
Boston, MA 02129
Phone: 617-374-8800
www.lavoiegroup.com 
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Donna LaVoie to Speak on The Habits of Highly Successful Financial Executives Panel

Thursday, February 27, 2014
11:30 a.m. - 1:00 p.m.
KPMG, Two Financial Center, Boston MA

What are the qualities that distinguish successful financial executives? 

Join us as we explore the technical requirements, character essentials and skill sets necessary of high achieving financial executives. 

Speakers include:  

describe the imageDonna LaVoie, President & CEO, LaVoie Group

Donna has over 20 years in business strategy, corporate communications, public and investor relations. Since starting the agency in 2001, Donna's efforts combine building the agency's pharmaceutical and life science practices, strategic direction and core competencies. Under Donna’s leadership, LaVoie Group has become the acknowledged leader in life science and pharmaceutical communications and recognized as a top 25 independent healthcare agencies in the US. For the past four years, LaVoie Group has been recognized by the League of American Communications Professionals for agency awards. Over the last three years, the firm has received 16+ prestigious PR and marketing awards for their efforts on behalf of their clients.

Donna is a frequent speaker and has been published on a variety of subjects including integrated and crisis communications, investor and public relations best practices. She holds a Bachelor of Science in Management from Lesley College and has completed a strategic marketing program at The Wharton School. Donna is also a member of the Senior Roundtable at the National Investor Relations Institute, is a part co-Chair of MassBio’s communications and marketing committee and currently serves Advamed’s host and welcome committee for the 2013 conference.

 

HamiltonJackie Barry Hamilton, CFO, Intronis

As CFO, Jackie manages Intronis’ finance function and partners with our operating managers to help deliver our world-class backup solution. She joins the company from Monster Worldwide, where she was divisional CFO of Monster Worldwide Technologies and, prior to that, a corporate finance vice president. A veteran of the IT services market, Jackie was CFO of Corporate Software, where she led financial operations and managed its successful acquisition by Level 3 Communications. Following the purchase, Hamilton served as senior vice president of the Information Services Group of Level 3 Communication.

A graduate of Simmons College, Jackie received her master’s degree in finance from Boston College.

GridleyJennifer Gridley, Director, Enterprise Market Intelligence, athenaHealth

Jennifer is Director, Enterprise Market Intelligence for athenaHealth, a provider of cloud-based services for electronic health records (EHR), practice management and care coordination with a market cap of $5billion.

Jennifer has been with athenaHealth since 2008, and in her current role is focused on equipping leadership, sales, client development and marketing teams with actionable, world-class insight that drives new revenue opportunity and builds athenaHealth's awareness, influence and loyalty among enterprise clients and sales targets.  Previously she served as Chief of Staff and Director of Special Projects for CEO Jonathan Bush, and launched the company's award-winning Investor Relations program.

Jennifer holds an MBA from Babson College, and a BS from Bentley University.

This panel will be moderated by Beth Kurth, President, Boston Women Finance.

 Registration

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Chelsea Therapeutics Announces FDA Accelerated Approval of NORTHERATM (Droxidopa) for the Treatment of Symptomatic NOH

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Reuters
Update 2--U.S. FDA Okays Chelsea Therapeutics Drug for Low Blood Pressure
February 18, 2014
Toni Clarke

Reuters reporter Toni Clarke reported, “the FDA followed the recommendation and approved the drug on an "accelerated" basis. This allows for approval a drug to treat a serious disease based on an intermediate measure while the company conducts more trials.”

Associated Press
Chelsea Therapeutics Blood Press Drug Approved
February 18, 2014
Matthew Perrone 

The Associated Press noted in positive approval coverage that this significant milestone "marks a major comeback for the company and its drug."

Bloomberg
Chelsea Wins U.S. Approval for Fainting Medicine Northera
February 18, 2014
Anna Edney

Anna Edney of Bloomberg reported that Chelsea Therapeutics won U.S. approval for its drug to prevent sudden drops in blood pressure, the company’s first product to reach the market. Edney included a quote by Norman Stockbridge, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research noting that “People with neurogenic orthostatic hypotension are often severely limited in their ability to perform routine daily activities that require walking or standing.

The Wall Street Journal
Chelsea Therapeutics' Northera Receives Accelerated FDA Approval
February 18, 2014
Erin McCarthy 

The Wall Street Journal reported that “the U.S. Food and Drug Administration granted accelerated approval of Northera, its treatment of symptomatic neurogenic orthostatic hypotension.”

TheStreet.com
Chelsea Therapeutics Wins FDA Approval for Northera
February 18, 2014
Adam Feuerstein

Adam Feuerstein of TheStreet.com interviewed Chelsea president and CEO Joe Oliveto following the FDA approval announcement. "I love the [Northera] label…We think it is a doctors' normal standard practice to assess the efficacy of any drug periodically." Feuestein also noted that “Chelsea avoids a worst-case scenario under which FDA might have restricted the drug's use to no more than two weeks.”

FierceBiotech
Chelsea Wins FDA Nod for Once-Spurned Northera, But Success Isn't Guaranteed
February 18, 2014
Damian Garde

In its second trip through the FDA, Chelsea Therapeutics' ($CHTP) antidizziness drug came out a winner, securing approval to fight faintness in patients with a rare disorder, but not without a daunting label and some strings attached.

Northera is now approved to treat lightheadedness associated with neurogenic orthostatic hypotension (NOH), a blood-pressure-lowering disorder tied to neurodegenerative ailments like Parkinson's disease. Chelsea intends to launch the oral drug in the second half of the year, targeting a U.S. patient population the company said is as large as 150,000. Analysts figure the drug could top out between $300 million and $450 million a year, although Chelsea has yet to discuss its pricing.

But the company may not be able to pull off a speedy launch of the once-rejected drug thanks to Northera's label. The treatment will carry a black-box warning due to its risks of increasing patients' blood pressure while they're lying down, and the FDA is cautioning those taking Northera to sleep with their heads elevated to cut back on the drug's stroke dangers. Furthermore, because the agency approved the drug through its accelerated orphan pathway, regulators looked at only two-week efficacy data and thus consider Northera's long-term benefits undemonstrated.

This 3-part webinar series is specifically geared toward the non-science professional who needs to better understand industry terminology, science, techniques and issues. This series provides an overview of the science and technology used to enable discovery and the processes scientists use to discover new therapeutics.

Investors seemed to struggle with what to make of the strongly worded label, as Chelsea's shares initially dipped on the postmarket announcement before soaring more than 30%. The Northera saga has made for some years-long bipolarity for Chelsea's stock price, but, hovering around $6.70 on Tuesday evening, the company's postapproval value is its highest since January 2011.

No matter Wall Street's reaction, the approval is a net win for Chelsea and Dainippon Sumitomo, which holds Asian rights to the drug. Northera is the first new NOH treatment in nearly 20 years, according to the company. Chelsea has a game plan for expanding its market share, preparing for a placebo-controlled study on about 1,400 patients with hopes of "definitively" proving Northera's lasting clinical benefit, the company said.

Safety concerns are hardly new for Northera, which endured an FDA rejection in 2012 due in part to agency worries about the hypertension risks now spelled out on its label. After piling on more efficacy data, Chelsea still faced some serious skepticism from FDA staff in the second go-round, but a panel of advisers voted in favor of approval in part because of the lack of viable treatments for NOH sufferers.

MedPage Today
FDA OKs Northera for Hypotension
February 18, 2014
Kristina Fiore

The FDA has approved droxidopa (Northera) for the treatment of neurogenic orthostatic hypotension, a rare disease that results in a drop in blood pressure when patients try to stand up.

The drug was passed up for approval 2 years ago when the FDA asked for more data from an additional clinical trial.

Approval stems from two clinical trials, each 2 weeks long, in which patients on droxidopa reported less dizziness, lightheadedness, feeling faint, or feeling as if they might black out than those on placebo.

The FDA noted, however, that the drug was OK'd under its accelerated approval program, which allows it to go on-market for demonstrating an effect on an "intermediate clinical measure" -- in this case, short-term relief of dizziness.

Drugmaker Chelsea Therapeutics, based in Charlotte, N.C., will have to demonstrate the drug's long-term benefit of extended dizziness relief in post-approval trials.

In its press release, the FDA emphasized that the "durability of the improvement in patient symptoms beyond 2 weeks has not been demonstrated."

Droxidopa will come with a boxed warning on the risk of increased blood pressure while lying down, which can cause stroke. FDA also warned it's essential that clinicians remind patients to sleep with their head and upper body elevated, and that supine blood pressure needs to be monitored before and during treatment, and more frequently when increasing doses. The drug is available in 100 mg, 200 mg, and 300 mg capsules.

In the two trials, the most common adverse events were headache, dizziness, nausea, high blood pressure, and fatigue.

Last month an FDA panel voted overwhelmingly in favor of approval (16 to 1) for droxidopa, but 2 years earlier nearly that same panel had been split on approval.

Following that advisory committee meeting, the FDA did not approve the drug, telling Chelsea Therapeutics it needed to submit more data from an additional trial.

Many panel members voting in favor of approval at the most recent advisory committee meeting said FDA should limit the drug to short-term use only, given the lack of long-term data.

Droxidopa is a pro-drug for norepinephrine, converted both peripherally and centrally, as it crosses the blood-brain barrier. It acts as a vasoconstrictor which, in theory, should help patients retain adequate blood pressure when they stand up from sitting or supine positions.

BioWorld Today
Chelsea’s Northera Wins FDA Approval in NOH; Black Box Warning
February 19, 2014
Randy Osborne

The long, hazard-fraught road for Chelsea Therapeutics International Ltd. with Northera (droxidopa) – including unfavorable briefing documents, followed by a positive advisory committee (adcom) vote – came to a happy end with approval of the drug by the FDA for neurogenic orthostatic hypotension (NOH), or a sudden drop in blood pressure when the patient stands up.

Ahead of the news Tuesday afternoon, Chelsea’s shares (NASDAQ:CHTP) halted trading at $4.95.

Northera bears a boxed warning about the risk of increased blood pressure while lying down. Patients are directed to sleep with their head and upper body elevated. Supine blood pressure should be monitored before and during treatment and more frequently when increasing doses, the warning says.

In January, an FDA panel voted 16-1 in favor of the approval of Charlotte, N.C.-based Chelsea’s orally active synthetic precursor of norepinephrine, though the panel was first skeptical, as was the agency itself, with regard to the durability of positive data gleaned from shorter-term studies. (See BioWorld Today, Jan. 13, 2014.)

It’s almost a reversal of what happened two years ago, when negative briefing documents appeared ahead of Northera’s first adcom, followed by a positive panel vote, followed by – instead of approval – a complete response letter from the unconvinced FDA, which wanted more trial data. (See BioWorld Today, Feb. 14, 2012, Feb. 24, 2012, and March 30, 2012.)

Deutsche Bank analyst Alethia Young predicted Northera could sell as much as $550 million worldwide, with $450 million of that in the U.S.

BioCentury
FDA Approves Chelsea's Northera
February 18, 2014 

FDA granted accelerated approval to Northera droxidopa from Chelsea Therapetuics International Ltd. (NASDAQ:CHTP) to treat neurogenic orthostatic hypotension (NOH). The label includes a boxed warning on the risk of increased blood pressure while lying down. Northera plans to launch the orally available synthetic precursor of norepinephrine next half but said it has not yet determined the price. The company said it was seeking accelerated approval of Northera and as part of the post-marketing commitments will conduct a confirmatory placebo-controlled trial to establish the start date for the trial, which is expected to enroll about 1,400 patients.

The approval came after market close on Tuesday. Chelsea was up $0.22 to $4.95 on the day. The company jumped $1.76 (36%) to $6.71 in early after-hours trading.

Need Help Navigating the Path to IPO? Join Us March 14, 2014

Janssen Labs/Johnson & Johnson InnovationProgram Overview

There's no denying the recent surge in IPOs for life science and med-tech companies with 51 in 2013 and early reports say there are already a number in the queue for 2014. This session will review key components in the legal, marketing and finance areas that should be considered by companies before commencing the process of going public. Join us for an in-depth session on planning a path to IPO and we hope you walk away with the real story behind how things work so you can make it happen for yourself.

Key topics:

  • Requirements of the SEC
  • At what stage should a company consider the public market
  • The importance of building the right company profile and team
  • Variable costs associated with being a public company
  • Life after going public

The "How to... Workshop" series is dedicated to giving you the keys to a successful business, from creation to exit. As with all our events, the "How to... Workshop" is interactive and informal so bring your questions with you!

   

Speakers

Donna LaVoie | CEO & Founder, LaVoie Strategic Communications Group
Megan Gates | Member, Mintz Levin
Christine Gallagher | Managing Director, Equity Capital Markets, SunTrust Robinson Humphrey

Who Should Attend

Senior management and board members of emerging growth companies in the life science and med-tech industries

Agenda

11:30 AM | Registration, Lunch, and Networking
12:00 PM | Welcome, Presentation & Q&A
1:30 PM | Program Close

Fees

Academic/Student Rate | $20
General Public | $35

Location

LabCentral
700 Main Street
Cambridge, MA 02139

Register Button

LaVoie Group Co-Hosts IPREX Global Leadership Conference with HB Agency

iprex

LaVoie Group is honored to be co-hosting this year's IPREX Global Leadership Conference in Boston on Friday and Saturday, February 28 and March 1, 2014.

This year's conference will focus on content marketing including topics such as developing orignal content for corporate clients, visual storytelling, web-based communications, social media and mark

IPREX was founded in 1983 to enable independent PR agencies to deliver high quality client work in major markets worldwide, and it has evolved into a tightly-knit peer group of more than 70 of the world's most successful communication agencies, of which LaVoie Group is proud to be a member.

 

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