8-K

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):
November 6, 2006 (November 4, 2006)

BIOMIMETIC THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware	000-51934	62-1786244
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

389-A Nichol Mill Lane, Franklin, Tennessee 37067
(Address of principal executive offices)

(615) 844-1280
(Registrant’s telephone number, including area code)

Not Applicable
(Former name, former address and former fiscal year,
if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

TABLE OF CONTENTS

EX-99.1 PRESS RELEASE 11/06/06

EX-99.2 SLIDES FROM THE DEWAR ORTHOPEDIC SOCIETY MEETING

Item 8.01. Other Events.

     On November 6, 2006, BioMimetic Therapeutics, Inc. (the “Company”) issued a press release announcing certain interim results for the evaluation of GEM OS1 ™ Bone Graft in the Company’s Canadian orthopedic pilot trial for foot and ankle fusion indications. Lead Canadian investigator, Timothy R. Daniels, M.D., presented the interim results on Saturday, November 4 at the Dewar Orthopaedic Society Meeting. The press release is attached hereto as Exhibit 99.1 and slides from the Dewar Orthopaedic Society Meeting summarizing the data are attached hereto as Exhibit 99.2, which are incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Number	Exhibit
99.1	Press Release dated November 6, 2006.
99.2	Slides from the Dewar Orthopaedic Society Meeting on interim results for the evaluation of GEM OS1 ™ Bone Graft.

SIGNATURE

     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

BIOMIMETIC THERAPEUTICS, INC.
By: Name:	/s/ Earl Douglas Earl Douglas
Title:	General Counsel

Date: November 6, 2006

EX-99.1

EXHIBIT 99.1

Contact:
Kearstin Patterson
Manager Corporate Communications
615-236-4419 (office)
615-517-6112 (mobile)
kpatterson@biomimetics.com

BioMimetic Therapeutics’ Clinical Investigator Highlights Results
of Orthopedic Clinical Trial in Canada

Franklin, Tenn – November 6, 2006 – BioMimetic Therapeutics, Inc. (BMTI) today announced interim results for the use of GEM OS1™ Bone Graft in the Company’s first orthopedic clinical trial in Canada for foot and ankle fusion indications. Lead Canadian investigator, Timothy R. Daniels, M.D., presented the results on Saturday, November 4^th at the Dewar Orthopaedic Society Meeting. Dr. Daniels made the following observations during his presentation:

- The results so far with GEM OS1 have been at least comparable to autograft, i.e., bone harvested from elsewhere in the patient’s own body and currently considered the gold standard, without the pain and morbidity associated with harvesting the autograft material.

- Over 70% of the patients included in this interim analysis have at least one risk factor for delayed healing or non-union. For example, 41% of the patients analyzed had failed a previous surgical treatment at the affected site.

- Following GEM OS1 treatment, a blinded independent radiologist found that by 12 weeks 85% of patients had some degree of fusion and 67% achieved greater than 50% osseous bridging as measured on CT scans (29 patients analyzed). These results are similar to recently published data using autograft, where 48% of patients demonstrated greater than 50% fusion mass at 12 weeks on CT scans.

- Upon clinical exam at 12 weeks, 67% of patients were full weight bearing (30 patients analyzed). By 16 and 24 weeks 90% and 100% of patients were full weight bearing (19 and 9 patients analyzed, respectively).

- There was no evidence of ectopic or otherwise abnormal bone formation.

- All the patients in this GEM OS1 trial have been spared the autograft bone harvesting procedure and have therefore benefited by the elimination of donor site pain and potential complications.

“I am very encouraged by the results I have seen with the use of GEM OS1 to enhance bone healing in foot and ankle fusion applications,” stated Dr. Daniels, associate professor at St. Michael’s Hospital, University of Toronto and co-founder of the Canadian Foot & Ankle Society. “The results observed to date show that GEM OS1 is a safe alternative to autograft — I haven’t seen any complications related to the product and the results are at least comparable to autogenous bone graft. We look forward to completion of patient enrollment and being able to fully analyze all the data from the larger trial involving 60 patients.”

The pilot study was designed to demonstrate safety and clinical utility to stimulate bone regeneration. The data from this study is the “first-in-man” clinical experience using GEM OS1 in a foot and ankle orthopedic application. The study was a multi-center, open label trial measuring fusion of joints within the foot. The data presented by Dr. Daniels were for the initial 32 patients enrolled in the study. The study was initially designed as a 20 patient pilot study and was expanded to 60 patients following authorization from the Canadian government.

Current orthopedic literature suggests overall rates of non-unions for foot and ankle fusions are greater than 10 percent with non-union rates higher in smokers, diabetics, obese individuals and patients who are undergoing revision surgeries. A majority of the subjects involved in the pilot study had one or more of these risk factors. Forty-four percent of the patients were considered obese, 25 percent had a history of smoking within the last five years, 13 percent had a history of diabetes and 41 percent had failed previous surgical treatment. Further, 44% of the subjects had multiple risk factors. The success observed in this study demonstrates the potential utility of GEM OS1 to treat patients who are at-risk to fail standard surgical treatment.

“The clinical results achieved thus far with GEM OS1 have exceeded our expectations” commented Dr. Samuel E. Lynch, president and CEO of BioMimetic. “These data show that the robust bone regeneration data previously observed in the jaws with GEM 21S, which utilizes the same PDGF-based technology as GEM OS1, are being translated to general orthopedic bone defects. While these observations need to be confirmed in larger trials, we believe that our product and product candidates have the potential to provide benefits to patients and surgeons across a wide array of periodontal and orthopedic applications.”

The slides highlighting the Canadian orthopedic clinical trial data presented by Dr. Daniels this weekend will be included in a Form 8-K filed with the Securities and Exchange Commission on Monday, November 6. The Form 8-K will be accessible on the Company’s website (www.biomimetics.com).

A conference call to discuss the Canadian orthopedic data and third quarter financial results, which will be released before market close today, will be held on Monday, November 6 at 5:00 p.m. EST. The call can be accessed by dialing 800-901-5248 (passcode 75663626). The international dial in number is 617-786-4512. The same passcode applies. Participants should dial in 15 minutes prior to the 5:00 p.m. call. A

live webcast of the conference call will be available on the Investor Relations section of BioMimetic’s website at www.biomimetics.com. The webcast will be archived for at least 30 days following the call.

GEM OS1

BioMimetic is developing GEM OS1 for use in open surgical treatment of fractures and bone fusions where the use of bone graft, a material used to augment bone healing, is indicated. GEM OS1 is designed to be placed directly into an open surgical site to stimulate bone regeneration. The combination of the two GEM OS1 components, recombinant human platelet-derived growth factor (rhPDGF) and Beta-tricalcium phosphate (b-TCP), is key to the product’s overall effectiveness. rhPDGF is intended to provide the biological stimulus for tissue regeneration by stimulating the in-growth and proliferation of osteoblasts, cells responsible for the formation of bone, while b-TCP provides a framework or scaffold for new bone growth to occur. According to securities research analyst reports, U.S. sales of bone grafting products and orthobiologics reached $1.3 billion in 2005, a 27% increase over 2004 sales.

Foot and Ankle Procedures

Foot and ankle fusion procedures are primarily performed in patients with severe osteoarthritis who do not respond to more conservative treatments. In a fusion procedure, the joint space between adjacent bones is surgically prepared and treated with a graft material to stimulate a fusion, or permanent connection of the two bone ends. This connection eliminates the pain associated with the movement of the joint. Typically, foot and ankle fusions are performed with bone material harvested from the patient (i.e. autograft), which is obtained as the result of a second surgical procedure. Harvesting autograft has significant drawbacks, which include often requiring a second surgery to harvest the graft, pain and morbidity associated with the second surgery and inconsistent volume and quality of the bone material harvested. GEM OS1, which is being developed as a fully synthetic substitute for autograft, eliminates the need for this second surgery. In foot and ankle surgery, non-unions are the most common post operative complication. As a result, there is a clear need for novel therapies such as GEM OS1 to improve healing rates in foot and ankle fusion applications.

About BioMimetic Therapeutics

BioMimetic Therapeutics, Inc. is developing and commercializing bio-active drug-device combination products for the healing of musculoskeletal injuries and disease, including periodontal, orthopedic, spine and sports injury applications. BioMimetic received marketing approval from the FDA for its first product, GEM 21S^®, as a grafting material for bone and periodontal regeneration following completion of human clinical trials, which demonstrated the safety and efficacy of its platform technology in this indication. Additionally, the Company has clinical trials ongoing for orthopedic bone healing indications. The Company’s product and product candidates all combine recombinant protein therapeutics with tissue specific scaffolds to actively stimulate tissue healing and regeneration.

Forward-looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on the current intent and expectations of the management of BioMimetic. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. There are many important factors that could cause actual results to differ materially from those indicated in the forward-looking statements. BioMimetic’s actual results and the timing and outcome of events may differ materially from those expressed in or implied by the forward-looking statements because of risks associated with the marketing of BioMimetic’s product and product candidates, unproven preclinical and clinical development activities, regulatory oversight, and other risks detailed in the company’s filings with the Securities and Exchange Commission, including the section entitled “Risk Factors” in its Prospectus dated May 12, 2006, filed with the Securities and Exchange Commission on May 12, 2006 and in its most recent quarterly report on Form 10-Q. Except as required by law, BioMimetic undertakes no responsibility for updating the information contained in this press release beyond the published date, whether as a result of new information, future events or otherwise, or for changes made to this document by wire services or Internet services.

For further information, visit www.biomimetics.com or contact Kearstin Patterson, manager corporate communications, at 615-236-4419.

EX-99.2

EXHIBIT 99.2

rhPDGF-BB A Novel Tissue Engineering System for the Future? Dr. Tim Daniels MD FRCSC Associate Professor St. Michael's Hospital University of Toronto

Delayed Union / Nonunion "In this study, the nonunion rate was 41%, the worst in the literature." Majority of the patients were post-traumatic. Highest incidence in patients with plafond/talus fractures A review of ankle arthrodesis: predisposing factors to nonunion. Frey C et al Foot Ankle Int. 1994 Nov;15(11):581-4.

Delayed Union / Nonunion 184 consecutive isolated subtalar arthrodesis Overall nonunion rate = 16% Nonunion rate: Nonsmokers - 8% Smokers - 27% Nonunion rate in: Primary fusion - 14% Revision fusion - 29% Isolated Subtalar Arthrodesis Easley ME, Trnka HJ, Schon LC and Myerson MS J Bone Joint Surg Am. 2000 May;82(5):613-24

Delayed Union / Nonunion 63 complex ankle or hindfoot fusions Grafton putty and Orthoblast used - demineralized bone graft Overall nonunion rate - 11% Use of demineralized bone matrix in ankle/hindfoot fusion. Thoradson DB and Kuehn S. Foot Ankle Int. 2003 Jul;24(7):557-60.

The Pilot Study Purpose Safety and clinical utility (i.e. performance) in representative bone regeneration model "First-in-man" clinical experience in foot and ankle orthopedic application Study Design Investigators: SMH, Toronto Western, British Columbia F/A Clinic Open-label pilot trial Independent radiological assessment (plain films and CT Scans) Number of Subjects: 20 (expanded to 60) Rigid fixation of fusion using screws (plate fixation excluded) Nine (9) month follow-up Endpoints: Radiographic Healing Union, AOFAS Score, Function, pain, QOL

Study Flowchart Procedure Screening Surgery Post-Treatment Follow-up Evaluations Post-Treatment Follow-up Evaluations Post-Treatment Follow-up Evaluations Post-Treatment Follow-up Evaluations Post-Treatment Follow-up Evaluations Post-Treatment Follow-up Evaluations Post-Treatment Follow-up Evaluations Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Visit 7 Visit 8 Visit 9 Within 21 Days of Surgery Day 0 Day 7-14 Wk 6 +-3 Days Wk 9 +-7 Days Wk 12 +-7 Days Wk 16 +-7 Days Wk 24 +-7 Days Wk 36 +-7 Days Informed Consent X1 Surgery X Clinical/Functional Assessments2 X X X X X X X Radiographic Outcomes3 X X X X X X X X X CT Scans4 X X X4 Quality of Life Assessments X X X X X Adverse Events/ Complications X X X X X X X X

Inclusion / Exclusion Criteria Key Inclusion Criteria REB approved informed consent Bone defect in foot/ankle fusion requiring bone graft No more than 4 screws ^ 16 years of age Key Exclusion Criteria Previous surgery with infection at fusion site Plate fixation or >9cc of bone graft (no more than 3 kits) History of cancer or current chemo-/radiotherapy Allergy to yeast-derived products Females intending to become pregnant (females of child-bearing potential must be practicing medically accepted method of birth control)

Surgical Procedure Surgical Technique Standard anesthesia protocol Entire joint exposed and denuded to subchondral bone Cortex is perforated to augment fusion Fusion hardware: screws (^ 4), supplemental pins; no plates Fixation must be rigid prior to wound closure Document start and stop times (first incision : wound closure)

Radiographic Endpoints Independent Radiological Assessment Osseous Bridging (CT Scan) Presence of Abnormal / Heterotopic Bone Formation Presence / resorption of TCP Hardware Complications

Number of Subjects 32 Mean Age 51 Gender Male - 13 (41%) Gender Female - 19 (59%) Mean Body Mass Index 29.9 (22 - 50) Smoking History Prior Smoking History - 13 (41%) Current Smoker - 6 (19%) Description of Injury / Deformity Primary Arthritis - 9 (29%) Rheumatoid Arthritis - 2 (6%) Post-Traumatic Injury - 12 (38%) Other - 12 (38%) Patient Demographics

Obese (^ 30 kg/m2) 14 (44%) Previous Surgery (revision) 13 (41%) History of Diabetes (Type I or II) 4 (13%) Smoking History within Last 5 yrs. 8 (25%) Subjects with multiple risk factors 14 (44%) Patient Risk Factors At-risk patient population included in pilot study

Adverse Events Event GEM OS1 Subjects With at Least One Adverse Event 21 Total Adverse Events 36 Surgical Complications 18 Serious Adverse Events 2 Infections (soft tissue) 3 Abnormal / Heterotopic Bone Formation 0 Adverse Events Attributable to Device 0 No device related AEs / SAEs reported to date

Timepoint Subjects Achieving FWB Status (%) Baseline N/A Week 6 2 / 32 (6%) Week 12 20 / 30 (67%) Week 16 17 / 19 (90%) Week 24 9 / 9 (100%) Clinical Outcomes All 24 week f/u patients have achieved FWB status

Timepoint Moderate or Complete (> 50%) Week 6 8 / 27 (30%) Week 12 18 / 27 (67%) Radiographic Outcomes Independent Radiologist Assessment: Osseous Bridging (CT Scans) 85% of subjects undergoing fusions in this current study had some degree of osseous bridging noted at 12 weeks on CT scan Recent CT outcomes reported with autograft looking at subtalar / triple fusions (23% at 6 weeks; 48% at 12 weeks)* *Coughlin et al, FAI, 2006

Conclusions Summary of Top Line Results for rhPDGF-BB / GEM OS1 To date this is a safe alternative to autogenous bone graft: Results comparable and suggest to be better than ABG without associated harvest morbidity No device related AEs/SAEs Additional RCTs are warranted to prove efficacy Expanded study accepted for product registration in Canada on basis of GEM 21S approval Rigid fixation and debridement are critical for efficacy of growth factors such as rhPDGF-BB Rigorous methodology including CT scans used to assess outcomes