Attached files
| file | filename |
|---|---|
| EX-99.2 - BIOMIMETIC THERAPEUTICS, INC. | v190026_ex99-2.htm |
| EX-99.3 - BIOMIMETIC THERAPEUTICS, INC. | v190026_ex99-3.htm |
| EX-99.1 - BIOMIMETIC THERAPEUTICS, INC. | v190026_ex99-1.htm |
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): July 7, 2010 (July 7,
2010)
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 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))
|
Item 7.01 Regulation FD Disclosure.
On July
7, 2010, BioMimetic Therapeutics, Inc. (the “Company”) issued a press release
announcing that Dr. Timothy Daniels, associate professor of orthopedic surgery
at the University of Toronto and St. Michaels Hospital presented the final, one
year results of the Company’s North American Pivotal Study comparing Augment
Bone Graft (“Augment”) to autograft in foot and ankle fusion surgery at the
American Orthopaedic Foot and Ankle Society (AOFAS) summer
meeting. The Company also announced that Dr. Nicholas Abidi, a
practicing orthopedic surgeon at Santa Cruz Orthopaedic Institute and an
investigator in the Company’s Augment North American Clinical Study, presented a
paper during the AOFAS meeting in which he summarized the results of a recently
completed economic study supported by the Company. The presentations
by both Dr. Daniels and Dr. Abidi are presented in more detail under Item 8.01
to this Current Report on Form 8-K.
A copy of
slides from that Dr. Daniels’ presentation are furnished as Exhibit 99.1 to this
Current Report on Form 8-K, and the slides from Dr. Abidi’s presentation are
furnished as Exhibit 99.2.
The
information in this Current Report and Exhibits 99.1 and 99.2 attached hereto
shall not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by
reference into any of the Company’s filings under the Securities Act of 1933, as
amended, or the Exchange Act, except as shall be expressly set forth by specific
reference in any such filing.
Item
8.01 Other Events.
On July
7, 2010, the Company announced the final, one year results of its North American
Pivotal Study comparing Augment to autograft in foot and ankle fusion surgery at
the AOFAS summer meeting. Dr. Timothy Daniels presented the entire
52-week data set, highlighting key 52-week endpoints, which demonstrate that out
of 16 secondary endpoint measures at the 52-week time point, 15 were
statistically significant for non-inferiority. Further, Augment
compared favorably to autograft with clinical healing rates of 87.8% and 88.3%,
and a therapeutic failure rate of 7.3% and 8.0%, respectively.
On July
7, 2010, the Company also announced results from its European Union Augment foot
and ankle fusion study, which included 108 patients at 11 clinical centers in
Europe. This study demonstrated only a 7% revision rate, which is
consistent with the therapeutic failure rate observed in the U.S. pivotal trial
for Augment and autograft (7.3-8.0%) and Canadian registration trial (10%), and
a safety profile that was consistent with all other studies of Augment to
date.
On July
7, 2010, Dr. Nicholas Abidi presented a paper during the AOFAS meeting in which
he summarized the results of a recently completed economic study supported by
the Company that quantifies the direct medical costs of harvesting autograft in
foot and ankle fusion procedures. The study concluded that the cost
of harvesting autograft is between $1,100 and $2,400 depending on the harvest
site, excluding the cost of treating complications associated with the harvest
procedure.
A copy of
the Company’s press release announcing these results is attached as Exhibit 99.3
to this Current Report on Form 8-K.
Item
9.01 Financial Statements and Exhibits.
(d) Exhibits
99.1 Slides
from Dr. Daniel’s presentation
99.2
Slides from Dr. Abidi’s presentation
99.3 Press
Release dated July 7, 2010
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:
|
/s/ Earl Douglas | |
| Name: | Earl Douglas | ||
| Title: | General Counsel | ||
Date: July
7, 2010