04/19/2011—MedPro Safety Products, Inc. and Greiner Bio-One GmbH jointly announced the market release of the VACUETTE® Premium Safety Needle System Tube-Touch. The product is initially being sold in the U.S. MedPro expects to obtain European CE Mark clearance during the second quarter 2011. The product is being manufactured by Greiner in facilities in Austria. The first production units are available for release to customers.
03/15/2011—MedPro announced the hiring of Mr. Gregory C. Schupp as MedPro’s chief operating officer beginning March 23, 2011. Mr. Schupp’s biography is provided on page 14.
02/03/2011—MedPro announced several corporate developments, including its receipt of the first royalty revenue from its Tube-Touch blood collection device. As well, the Company reported that it provided the first production samples of its passive safety winged blood collection set for human use to its manufacturing and marketing partner. In addition, MedPro announced plans to move its corporate headquarters in March 2011 to foster product incubation development in a collaborative environment.
10/06/2010—The Company announced that it completed the issuance of a final $5 million tranche of Senior Secured 14% Notes due in 2016 through a private placement with institutional investors managed by Cowen and Company, LLC. MedPro received roughly $4.6 million in net proceeds from the transaction. The terms of the Notes are the same as the Senior Secured Notes sold in the initial $25 million tranche announced September 1, 2010.
09/01/2010—MedPro announced that it completed the issuance of $25 million of Senior Secured 14% Notes due in 2016 through a private placement with institutional investors managed by Cowen and Company. SC Capital Partners, LLC also served as financial advisor to MedPro. The Senior Secured
14% Notes were issued by the Company’s newly formed subsidiary, MedPro Investments, LLC. The
Company received approximately $18.6 million in net proceeds after the establishment of a $4.5 million interest reserve and payment of offering expenses. MedPro expects to use the net proceeds to finance the development of its safety products and to retire debt.
07/22/2010—MedPro announced that it entered into a new agreement granting Greiner exclusive rights to manufacture, market, and distribute three safety blood collection and infusion products for a six-year term. The agreement superseded MedPro’s two prior agreements with Greiner. As well, MedPro transferred the rights to receive all royalties under the new agreement with Greiner to its subsidiary, MedPro Investments.
08/05/2010—MedPro issued a Promissory Note to Vision Opportunity Master Fund, Ltd. (VOMF), a Cayman Island investment fund, evidencing a loan by VOMF to the Company in the original principal amount of $500,000. In consideration of the loan, MedPro granted VOMF Warrants to purchase up to 83,335 shares of Common Stock at an exercise price of $3.00 per share.
06/30/2010—MedPro made a $450,000 draw under its credit agreement with VOMF. Total draws under the credit agreement totaled $1 million, which is the maximum aggregate principal amount available under the credit agreement. Under the terms of the agreement, MedPro issued a Warrant to purchase 75,002 shares of Common Stock at $3.00 per share to VOMF in connection with the draw.
06/04/2010—MedPro made a $300,000 draw under its credit agreement with VOMF. Per the terms of the agreement, MedPro issued a Warrant to purchase 50,001 shares of Common Stock at $3.00 per share to VOMF in connection with the draw. As well, VOMF extended the date on which all principal and interest is due and payable on VOMF’s $1,300,000 bridge loan to MedPro to September 30, 2010.
03/11/2010—MedPro entered into a Joint Development Agreement with Belgium-based Helvoet Pharmaceutical N.V. for the technical development and commercialization of MedPro’s prefilled safety syringe. Helvoet Pharma is a global manufacturer and supplier of pharmaceutical-grade coated rubber products, packaging components, and injectable drug closures.
03/03/2010—MedPro announced that it was scheduled to present at the Cowen and Company 30th
Annual Health Care Conference on March 8, 2010, at the Boston Marriott Copley Place in Boston, Massachusetts. Mr. W. Craig Turner, MedPro’s chief executive officer (CEO) and chairman of the Board of Directors, and Mr. Walter W. Weller, the president and a director of the Company, were scheduled to discuss MedPro’s leadership role in the emerging healthcare market for passive automatic safety technology. An audio webcast of MedPro’s presentation was made available through Cowen’s website.
01/19/2010—The Company purchased product development rights for a novel, fully passive Insulin Guard self-injector from Visual Connections, Inc., which is owned by Mr. Hooman Asbaghi. Mr. Asbaghi is the inventor of MedPro’s fully passive phlebotomy collection devices, including two versions of a safety blood collection holder, a passive intravenous (IV) catheter, and a safety blood collection set.
01/12/2010—MedPro agreed to acquire product development rights for a novel, fully passive safety IV catheter from a company owned by Mr. Asbaghi and Mr. Don Millerd. The Company has allowed its option to acquire the safety IV catheter to expire.
11/23/2009—The Company reported on its progress, which included five initiatives: (1) executed a Letter of Intent regarding the commercial development of the fourth product in MedPro’s current patent portfolio; (2) entered into an exclusive agreement with Advanced MedTech, Inc. (AMT), as described in greater detail under the entry on 09/28/2009; (3) continued development of its Winged Safety Blood Collection Set and deliverance of premarket prototypes to its customer for evaluation; (4) continued final product testing of the Tube-Touch blood collection device; and (5) continued to explore strategies to improve the liquidity and value of MedPro’s Common Stock.
09/28/2009—MedPro entered into an exclusive agreement with AMT. AMT is wholly owned by Mr. Asbaghi. Under the agreement’s terms, AMT is to provide MedPro with research and development (R&D), market research, product design and development, engineering, and other services as directed by MedPro. MedPro held the first right of refusal to all intellectual property (IP) in which Mr. Asbaghi had an interest and any products he developed.
09/09/2009—The Company announced the completion of preliminary testing and regulatory requirements for the VACUETTE® Premium Safety Needle System Tube-Touch model, a single-patient, multiple sample blood collection safety needle system. The VACUETTE® product also met U.S. Food and Drug
Administration (FDA) and International Organization for Standardization (ISO) requirements; customer and MedPro stipulated testing protocols; and safety and efficacy standards.
06/25/2009—MedPro’s Board of Directors authorized the repurchase of up to one million shares of the Company’s Common Stock. The shares were expected to be available for repurchase from time to time at MedPro’s discretion in open market transactions or privately negotiated transactions, subject to market conditions and other factors, including black-out periods during which the Company and its insiders are prohibited from trading in its Common Stock.
03/30/2009—MedPro announced that its two largest Preferred Stockholders, Vision Opportunity Master Fund, LLC (a New York based private equity firm) and Vision Capital Advantage Fund, agreed to exercise a portion of their Stock Purchase Warrants for cash totaling $3 million and to exchange all of their remaining outstanding Warrants for shares of new Series C Convertible Preferred Stock. Together, the two Vision funds acquired 1,571,523 shares of Series C Stock as a result of the Warrant exercise and exchange.
Glossary
510(k)-cleared Device—Section 510(k) of the Food, Drug, and Cosmetic Act requires device manufacturers to notify the FDA at least 90 days in advance of an intent to market a medical device. The FDA may then issue a 510(k) marketing clearance, allowing the commercialization of the device, upon making a determination that the device to be introduced into commercial distribution is safe and effective.
Acute Care—Medical care administered, frequently in a hospital or by nursing professionals, for the treatment of a serious injury or illness or during recovery from surgery. Medical conditions requiring acute care are typically periodic or temporary in nature, rather than chronic.
American Nurses Association (ANA)—A professional organization representing the interests of over three million registered nurses through its constituent member nurses associations, its organizational affiliates, and its workforce advocacy affiliate, the Center for American Nurses.
Ampoules—Small bottles that contain a drug, especially a sealed sterile container for injection by needle.
Anti-blunting—A device that allows the medical professional to fill the syringe, remove an outer needle to reveal a fresh, sharp needle within the outer needle, thus eliminating the requirement to replace the needle on the syringe prior to injecting the patient.
Average Daily Census—The average number of staffed beds that are occupied each day. The average daily census is calculated by dividing the total inpatient days by 365 days.
Bloodborne Pathogens—Disease-producing microorganisms spread by contact with blood or other body fluids contaminated with blood from an infected person.
Bloodborne Pathogens Standard (BPS)—A standard developed, promulgated, and enforced by the Occupational Safety and Health Administration (OSHA) directing employers to protect employees from occupational exposure to blood and other potentially infectious material.
Cannula—A small flexible tube inserted into a body cavity to drain fluid or introduce medication.
CE Mark—The regulatory approval system for all medical devices to be sold in the EU. It is used to indicate that a product conforms to the relevant EU health, safety, and environmental quality standards.
Federal Needlestick Safety and Prevention Act—A modification to OSHA’s Bloodborne Pathogens Standard (BPS) to make more specific OSHA’s requirement for employers to identify, evaluate, and implement safer medical devices. It also mandated additional requirements for maintaining a sharps injury log and involving non-managerial healthcare workers in evaluating and choosing devices. The Needlestick Safety and Prevention Act was signed into law on November 6, 2000.
First Right of Refusal—A provision in an agreement stating that a specified party must be given an opportunity before any others to either accept or reject an offer.
Flushing—Ensuring catheter pathways are clear, such as by the positive pressure flushing techniques used in the Interlink® system, which offers consistently low levels of negative fluid displacement (catheter
reflux). Flushing efficacy can be calculated by measuring removal of red blood cells from injection sites.
Fully Passive—The model does not require the operator to specifically activate the safety features of the needle but rather they are activated through normal use.
Good Manufacturing Practice (GMP)—In the U.S., the Quality System Regulation (QSR) overseen by the FDA, which includes requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing medical devices intended for human use.
Hepatitis—Inflammation of the liver caused by a virus or a toxin.
Human Immunodeficiency Virus (HIV)—The virus that causes acquired immune deficiency syndrome (AIDS). It replicates in and kills the helper T-cells.
Hypodermic—A hollow needle used with a syringe that has been adapted for injection beneath the epidermis.
Intravenous—Within or by means of a vein.
Intravenous (IV) Catheter—A small needle with a hollow tube inserted into a vein and used to give medicines or fluids.
ISO 13485:2003—Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements applicable to medical devices and related services.
Luer Lock—A type of connector with a locking mechanism that is used extensively in medical and laboratory applications.
Luer Slip—Whereas luer lock fittings are securely joined by means of a tabbed hub on the female fitting, which screws into threads in a sleeve on the male fitting, luer slip fittings conform to luer taper dimensions (a standardized system of small-scale fluid fittings used for making leak-free connections between a male-taper fitting and its mating female part on medical and laboratory instruments) and are pressed together and held by friction (they have no threads).
Minimum Volume Contracts—Contracts designed to require distributors to purchase minimum unit volumes of a product.
Needlestick Injuries—Penetrating wound caused by mishandling a needle. Needlestick injuries are of the foremost concern to healthcare workers due to their potential to transmit infectious diseases or unwanted medication into a healthy individual.
Occupational Safety and Health Act—A U.S. federal law that requires employers to provide employees with a workplace that is relatively free of hazardous conditions.
Occupational Safety and Health Administration (OSHA)—A federal agency under the U.S. Department of Labor responsible for establishing and enforcing safety and health standards in the workplace for most businesses and industries in the U.S.
Passive—Safety mechanisms that are activated automatically, requiring no action by the user.
Percutaneous—Administered, removed, or absorbed by way of the skin, as an injection, needle biopsy, or transdermal drug.
Phlebotomy—The letting of blood for transfusion, diagnosis, or experiment, and especially formerly in the treatment of disease.
Prefilled—A disposable syringe containing a single, premeasured dose intended for one patient that is sterile and ready for use.
Private-label—Brand owned not by a manufacturer or producer but by a retailer or supplier that gets its goods made by a contract manufacturer under its own label. Also called private brand.
Sharp—A general term for a needle or similar pointed object.
Vacuum Tube—A type of test tube that contains a vacuum that automatically aspirates blood into itself. The tubes are attached to a needle and hub and can be made of glass or plastic.
Venous Blood Draws—The process of obtaining a sample of blood from a vein.
Vials—Small containers for holding liquids. A small bottle that contains a drug (especially a sealed sterile container for injection by needle).
White Paper—A document written in essay style that provides an in-depth analysis of a technology, trend, product, or process. White papers are predominantly informational rather than promotional material.
Winged Butterfly—A needle with two plastic wings on either side, which are designed to allow the user to grasp the needle very close to the end in order to ensure accuracy. The butterfly needle also has flexible tubing and another needle at the other end (the “hub”), which is generally sheathed with some sort of rubber-like material. This needle, unlike the exposed side, is not sharp. After the needle is inserted into the vein, the operator can push vacuum tubes into the hub to draw blood.
Jeffrey J. Kraws and Karen B. Goldfarb Phone: (609) 306-2274
Fax: (609) 395-9339
Email: [email protected]
Web: www.crystalra.com
Legal Notes and Disclosures: This report has been prepared by MedPro Safety Products, Inc. (“MedPro” or “the Company”) with the assistance of Crystal Research Associates, LLC (“CRA”) based upon information provided by the Company. CRA has not independently verified such information. In addition, CRA has been compensated by the Company in cash of fifty-five thousand U.S. dollars and one hundred seventy-five thousand options/warrants for its services in creating this report, for updates, and for printing costs.
Some of the information in this report relates to future events or future business and financial performance. Such statements constitute forward-looking information within the meaning of the Private Securities Litigation Act of 1995. Statements that express opinions, expectations, beliefs, plans, objectives, assumptions, or projections regarding future events or future results are based upon the current views of MedPro’s management about future events. Words or phrases such as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “seek,” “intend,” “may be,” “objective,” “plan,” “predict,” “project,” “will be,” and similar words or phrases, or the negative thereof, are intended to identify such forward-looking statements. These forward-looking statements include all matters that are not historical facts. These forward-looking statements are not guarantees of future performance and are subject to numerous assumptions, risks, and uncertainties. Actual events or results may differ from those discussed due to, among other things, the risks described in MedPro’s reports on its 10-K, 10-Q, press releases, and other forms filed from time to time. The content of this report with respect to MedPro has been compiled primarily from information available to the public released by the Company. MedPro is solely responsible for the accuracy of that information. Information as to other companies has been prepared from publicly available information and has not been independently verified by MedPro or CRA. Certain summaries of scientific activities and outcomes have been condensed to aid the reader in gaining a general understanding. For more complete information about MedPro, the reader is directed to the Company’s website at www.medprosafety.com. This report is published solely for information purposes and is not to be construed as an offer to sell or the solicitation of an offer to buy any security in any state. Past performance does not guarantee future performance. Additional information about MedPro and its public filings, as well as copies of this report, can be obtained in either a paper or electronic format by calling (859) 225-5375.