CRY » Topics » Hemostase

This excerpt taken from the CRY 10-Q filed Apr 30, 2009.

Hemostase

Revenues from the sale of Hemostase for the three months ended March 31, 2009 are a result of CryoLife’s marketing and distribution of Hemostase, which began in the second quarter of 2008. Revenues from Hemostase could be adversely impacted by the Company’s lawsuit with Medafor. See Part II, Item 1, “Legal Proceedings.”

These excerpts taken from the CRY 10-K filed Feb 19, 2009.

Hemostase

In the U.S. the Company markets and distributes Hemostase in cardiac and vascular surgery through its field representatives and cardiac specialists. The Company markets and distributes Hemostase for cardiac, vascular, and general surgery in international markets (except China and Japan) through direct field representatives employed by Europa and other independent distributors.

Hemostase

In the U.S. the Company markets and distributes Hemostase in cardiac and vascular surgery through its field representatives and cardiac specialists. The Company markets and distributes Hemostase for cardiac, vascular, and general surgery in international markets (except China and Japan) through direct field representatives employed by Europa and other independent distributors.

Hemostase

In the
U.S. the Company markets and distributes Hemostase in cardiac and vascular surgery through its field representatives and cardiac specialists. The Company markets and distributes Hemostase for cardiac, vascular, and general surgery in international
markets (except China and Japan) through direct field representatives employed by Europa and other independent distributors.

European Operations

The Company markets its products in the EMEA region through its European subsidiary, Europa based in Guildford, England. Europa, with its
team of approximately 21 employees, provides customer service, logistics, marketing, and clinical support to cardiac, vascular, thoracic, and general surgeons throughout the EMEA region. Europa markets and distributes the Company’s complete
range of products through its direct sales representatives in Great Britain and Germany and a network of independent distributors in the EMEA region. Europa also distributes tissue to certain hospitals in the EMEA region.

STYLE="margin-top:18px;margin-bottom:0px">Backlog

The limited supply of tissue that is donated
and available for processing can result in a backlog of orders in the Company’s human tissue business, primarily for those tissues used in pediatric surgeries. The amount of backlog fluctuates

 


10









based on the tissues available for shipment and varies based on the surgical needs of specific cases. The Company’s backlog is generally not considered
firm and must be confirmed with the customer before shipment. The Company currently does not have a backlog of orders related to BioGlue or Hemostase.

SIZE="2">Competition

Hemostase

In the
U.S. the Company markets and distributes Hemostase in cardiac and vascular surgery through its field representatives and cardiac specialists. The Company markets and distributes Hemostase for cardiac, vascular, and general surgery in international
markets (except China and Japan) through direct field representatives employed by Europa and other independent distributors.

European Operations

The Company markets its products in the EMEA region through its European subsidiary, Europa based in Guildford, England. Europa, with its
team of approximately 21 employees, provides customer service, logistics, marketing, and clinical support to cardiac, vascular, thoracic, and general surgeons throughout the EMEA region. Europa markets and distributes the Company’s complete
range of products through its direct sales representatives in Great Britain and Germany and a network of independent distributors in the EMEA region. Europa also distributes tissue to certain hospitals in the EMEA region.

STYLE="margin-top:18px;margin-bottom:0px">Backlog

The limited supply of tissue that is donated
and available for processing can result in a backlog of orders in the Company’s human tissue business, primarily for those tissues used in pediatric surgeries. The amount of backlog fluctuates

 


10









based on the tissues available for shipment and varies based on the surgical needs of specific cases. The Company’s backlog is generally not considered
firm and must be confirmed with the customer before shipment. The Company currently does not have a backlog of orders related to BioGlue or Hemostase.

SIZE="2">Competition

Hemostase

The Company’s Hemostase product competes with thrombin products, including King Pharmaceuticals, Inc.’s Thrombin JMI, ZymoGenetics, Inc.’s Recothrom, and Omrix Biopharmaceuticals, Inc.’s (a Johnson & Johnson Company) Evithrom; and surgical hemostats, including Pfizer, Inc.’s Gelfoam, C.R. Bard, Inc.’s Avitene, Baxter International, Inc.’s FloSeal, and Ethicon, Inc.’s Surgicel, Surgiflo, and Surgifoam products. In addition, Starch Medical Inc. has a hemostatic product that has CE approval and that will compete in the future outside of the U.S. A number of companies have surgical hemostat products under development. Other medical device, pharmaceutical, and biopharmaceutical companies may also develop competitive products. The Company’s Hemostase product competes on the basis of its safety profile, its clinical efficacy, and ease of use. Many of the Company’s current and potential competitors have substantially greater financial and personnel resources than the Company. These competitors may also have greater experience in developing products, conducting clinical trials, and obtaining regulatory approvals. Certain of these competitors may obtain patent protection, approval, or clearance by the FDA or foreign countries, or product commercialization earlier than the Company. The Company may also compete with companies that have superior manufacturing efficiency and marketing capabilities. Any of these competitive disadvantages could materially adversely affect the Company.

Hemostase

The Company’s Hemostase product competes with thrombin products, including King Pharmaceuticals, Inc.’s Thrombin JMI, ZymoGenetics, Inc.’s Recothrom, and Omrix Biopharmaceuticals, Inc.’s (a Johnson & Johnson Company) Evithrom; and surgical hemostats, including Pfizer, Inc.’s Gelfoam, C.R. Bard, Inc.’s Avitene, Baxter International, Inc.’s FloSeal, and Ethicon, Inc.’s Surgicel, Surgiflo, and Surgifoam products. In addition, Starch Medical Inc. has a hemostatic product that has CE approval and that will compete in the future outside of the U.S. A number of companies have surgical hemostat products under development. Other medical device, pharmaceutical, and biopharmaceutical companies may also develop competitive products. The Company’s Hemostase product competes on the basis of its safety profile, its clinical efficacy, and ease of use. Many of the Company’s current and potential competitors have substantially greater financial and personnel resources than the Company. These competitors may also have greater experience in developing products, conducting clinical trials, and obtaining regulatory approvals. Certain of these competitors may obtain patent protection, approval, or clearance by the FDA or foreign countries, or product commercialization earlier than the Company. The Company may also compete with companies that have superior manufacturing efficiency and marketing capabilities. Any of these competitive disadvantages could materially adversely affect the Company.

Hemostase

SIZE="2">The Company’s Hemostase product competes with thrombin products, including King Pharmaceuticals, Inc.’s Thrombin JMI, ZymoGenetics, Inc.’s Recothrom, and Omrix Biopharmaceuticals, Inc.’s (a Johnson & Johnson
Company) Evithrom; and surgical hemostats, including Pfizer, Inc.’s Gelfoam, C.R. Bard, Inc.’s Avitene, Baxter International, Inc.’s FloSeal, and Ethicon, Inc.’s Surgicel, Surgiflo, and Surgifoam products. In addition, Starch
Medical Inc. has a hemostatic product that has CE approval and that will compete in the future outside of the U.S. A number of companies have surgical hemostat products under development. Other medical device, pharmaceutical, and biopharmaceutical
companies may also develop competitive products. The Company’s Hemostase product competes on the basis of its safety profile, its clinical efficacy, and ease of use. Many of the Company’s current and potential competitors have
substantially greater financial and personnel resources than the Company. These competitors may also have greater experience in developing products, conducting clinical trials, and obtaining regulatory approvals. Certain of these competitors may
obtain patent protection, approval, or clearance by the FDA or foreign countries, or product commercialization earlier than the Company. The Company may also compete with companies that have superior manufacturing efficiency and marketing
capabilities. Any of these competitive disadvantages could materially adversely affect the Company.

Hemostase

SIZE="2">The Company’s Hemostase product competes with thrombin products, including King Pharmaceuticals, Inc.’s Thrombin JMI, ZymoGenetics, Inc.’s Recothrom, and Omrix Biopharmaceuticals, Inc.’s (a Johnson & Johnson
Company) Evithrom; and surgical hemostats, including Pfizer, Inc.’s Gelfoam, C.R. Bard, Inc.’s Avitene, Baxter International, Inc.’s FloSeal, and Ethicon, Inc.’s Surgicel, Surgiflo, and Surgifoam products. In addition, Starch
Medical Inc. has a hemostatic product that has CE approval and that will compete in the future outside of the U.S. A number of companies have surgical hemostat products under development. Other medical device, pharmaceutical, and biopharmaceutical
companies may also develop competitive products. The Company’s Hemostase product competes on the basis of its safety profile, its clinical efficacy, and ease of use. Many of the Company’s current and potential competitors have
substantially greater financial and personnel resources than the Company. These competitors may also have greater experience in developing products, conducting clinical trials, and obtaining regulatory approvals. Certain of these competitors may
obtain patent protection, approval, or clearance by the FDA or foreign countries, or product commercialization earlier than the Company. The Company may also compete with companies that have superior manufacturing efficiency and marketing
capabilities. Any of these competitive disadvantages could materially adversely affect the Company.

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