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ViCroTM

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CUSTOMER TESTIMONIALS

I am writing to express my sincere gratitude for ViCro’s expertise in regulatory affairs, reimbursement, and market research.  Regenesis is a medical device company located in Scottsdale AZ.  Our platform science is based on pulsed radio frequency energy (PRFE) with applications in the tissue regeneration market, specifically targeting post-operative pain and edema in superficial soft tissues.  Our product, the Provant® Therapy System, uses PRFE to trigger skin cells to produce proteins that impact the endogenous opioid and other regenerative pathways.  ViCro has been instrumental to Regenesis’ success based upon your regulatory, reimbursement and market research programs. 

Regulatory

ViCro’s knowledge of the United States Food and Drug Administration’s regulatory processes on both the 510(k) and PMA pathways has been invaluable to Regenesis.  The Company was successful in receiving it's second 510(k) in 2010.  Understanding the ability to pursue a 510(k) rather than a PMA allows the Company to get-to-market Provant on a faster commercial route. 

Reimbursement

ViCro’s expertise in reimbursement provided Regenesis the opportunity to understand the competitive landscapae of other technologies.  This work enables us to strategically position the pricing of Provant within the government, commercial, self-insurers and workers’ compensation arenas.

Market Research

ViCro’s indepth analysis of the Company’s market place set the strategic direction for the Company to target our marketing and sales efforts in a laser-like manner to generate revenues and attain cash profitability.  ViCro also introduced us to the Mayo Clinic’s Center for Procedural Innovation to conduct needed preclinical studies for demonstrating the effectiveness of PRFE in known models for better adoption by prescribing clinicians.

Virginia S Rybski, President, CEO and Director, Regenesis Biomedical, Inc.

Thank you for all your work on the Normocarb HF NDA.  We would not have been able to obtain approval without your tireless energy and skillful work.  Your personal contribution of the ViCro team proved critical in the completion of a successful NDA and Orphan Drug Designation.  Our approval process began from a unique point.  Few drugs are approved as devices first.  This presented an interesting starting point and required some strategic planning to create the drug track we desired.  Had we done this and been unable to execute, it would have been catastrophic for my company.  You were a key team member in formulating and executing this early stage strategy with the FDA.

Your technical knowledge of the regulations was flawless from the beginning.  We were never questioned about a major deficiency and the minor deficiencies you were able to identify before the FDA.  Fixes were in place to minimize any delays.  More importantly, by doing this you were able to make a very small, inexperienced company look like they knew what they were doing at every turn.  The ViCro “system” proved to be extremely cost effective.  You brought the right people in at the right time.  We really got the expertise of five people for the price of two.  I don’t believe an NDA or Orphan Drug Designation have ever been obtained more cost effectively than ours.

Your knowledge of, and professional relationship with, the FDA organization as a whole allowed us to direct questions and get feedback from the right people all the time.  In addition, your non-confrontational style of dealing with the FDA matched ours exactly.  This proved to be the winning formula and will continue to help us as subsequent indications are sought.  Possibly more importantly, your enthusiasm, energy, and focus on our project not only completed a project I think we all thought was a long shot, but did it six months earlier than our best case scenario.  Ann, I cannot thank you enough.

Walter O’Rouke (President, CEO) and Sheldon Tobe, MD (Chief Medical Officer), Dialysis Solutions Inc.

The team at ViCro,LLC provided our company with the seasoned combination of regulatory expertise, clinical acumen, and competent management that we needed to navigate through FDA's drug development process. ViCro's solid track record of regulatory application preparation, filing, acceptance, and approvals is only surpassed by their years of professional relationship-building with FDA insiders. ViCro's president, Ann Rose, PhD, provided us with valuable insights and strategic advice for overcoming regulatory challenges. At FDA face-to-face meetings, we were entirely comfortable that ViCro's knowledgeable, tactful and collegial approach would lead to the best possible outcome. ViCro is a nimble, sophisticated organization that we would rely on again and highly recommend.

Stephane Allard, MD  CMO, EpiCept

NuVue Therapeutics, at this time, is please to say a few words about our excellent relationship and experience with Dr. Ann H. Rose and her company, ViCro LLC, and its abilities as an FDA Consultant in dealing with both the Device and Pharma sides of a medical business.

NuVue has had dealings with Dr. Rose's Company, ViCro LLC, and her associates for some ten years. ViCro has facilitated NuVue's ability in assessing the level of clinical efficacy of a number of products that have been under development; has provided sound regulatory strategy consistent with the Company's business strategies; and, in fact, has helped with the development of products and procedures dealing with both the Device and Pharma sides of our business.

ViCro as a Company has an extensive Consortium of experts, that a company such as NuVue is able to rely on in all aspects of preclinical, clinical, manufacturing and regulatory matters. ViCro's Consortium of experts come from both academia, as well as industry and have experience with the regulatory processes of both the United States and abroad.

In short, ViCro is an excellent outsourced regulatory consulting firm, which has shown itself to be more than affordable to a small medical company like NuVue regarding all aspects of FDA regulatory issues. Dr. Rose and her Company have continually shown and proven to NuVue that her organization, aside of having a level of respect in the Industry, will, without question, fulfill all the responsibilities necessary in gaining FDA approvals as they are needed by the Company.

Roger S. Kolasinski, CEO, NuVue Therapeutics,Inc.

PharmaLink is a international medical regulatory consulting company, headquartered in the U.K with offices globally. Over the past decade we're partnered with ViCro, a boutique consulting company in the "development" phase of medical products. They consistently provide cutting-edge knowledge in all the development disciplines and sage regulatory strategies.  Their structure makes them very cost effective to customers. In addition, they outperform expectations on deliverables and have a courteous, attentive staff with a "hand-on' CEO.  They are our first go-to" on problematic issues.

Stephen Loughrey, CEO US Division – PharmaLink

I first met the ViCro team in 2000 when they were hired to do investor due diligence on a specialty pharmaceutical company that I was running.  They were specifically tasked with reviewing an especially complex Phase 2 drug development program involving a multi-component botanical drug substance with a novel indication.  I was extremely impressed with the team assembled:  They had a cutting-edge knowledge of the scientific and regulatory issues, and were a pleasure to work with.  Their assessment and guidance was helpful to both their client and my team.  Five years later I hired ViCro to help another company handle a foreign regulatory challenge related to a product safety challenge.  Again, just the right expertise and political savvy to help successfully navigate the challenge.   I  have been impressed by ViCro's ability to bring just the right team together to develop optimal regulatory strategy and to deliver approvals and clearances in record time.  

Janice E. Thompson, Ph.D., Independent Consultant Botanical Medical Products

Your professionalism is matched only by your congeniality.  ViCro always performs with the highest standards and skills.  Your knowledge and know how make each opportunity to work together valuable and enjoyable.  Thank you for the outstanding work!  We have a ViCro as a Preferred Resource on our list.

Cynthia Ekberg Tsai, Chairman, Viropro and President, ExecutiveAction

“on several occasions I have been pleased with the expert, cost effective regulatory services provided by ViCro involving our interactions with several divisions at FDA.”

Jack Talley President & Chief Executive Officer EpiCept Corp.

Based on our many years of working cooperatively spanning over twenty years, I am most pleased to recommend you and ViCro to any of your prospective clients.

We first worked together when I was the CEO of Genex, Inc, located in Gaithersburg, MD, where you served as the Vice President of Business Development and you were responsible for Clinical and Regulatory Affairs, and for our relationship with the NIH and FDA.  Subsequently, you worked with me at OSI Pharmaceuticals, Inc when I was Chairmen and CEO, where you served in several Vice President level positions:  Clinical, Regulatory, and as the Program Manager of the joint OSI-Novartis Program in Wound Healing and Oral Mucositis.

After you left to start ViCro, I worked with you on several assignments involving companies that I served with as a Board Member: Merrimack Pharmaceuticals and Viroxis Pharma, among others.  I know that ViCro is a full service CRO and utilizes a large network of qualified associates and consultants in an efficient manner.  I am very pleased to recommend ViCro and you.

Gary Frashier, President and Founder, Management Associates

Ann Rose, founder and principal of ViCro, and I have been business associates and friends for over 20 years.   As the CEO of Gilbert Tweed International, a retained executive search firm with headquarters in New York City, Ann has worked closely with our bio-technology clients.   In fact, early on in both of our careers, I placed her, a true star,  at OSI Pharmaceutical because of her extraordinary relationships with the NIH.  Her experience, style of execution and knowledge of the venture and private equity worlds, simply make her the best. 

Janet Tweed, CEO, Gilbert Tweed International