0000000000-24-013467.txt : 20250228
0000000000-24-013467.hdr.sgml : 20250228
20241206103607
ACCESSION NUMBER: 0000000000-24-013467
CONFORMED SUBMISSION TYPE: UPLOAD
PUBLIC DOCUMENT COUNT: 2
FILED AS OF DATE: 20241206
FILED FOR:
COMPANY DATA:
COMPANY CONFORMED NAME: Beta Bionics, Inc.
CENTRAL INDEX KEY: 0001674632
STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
ORGANIZATION NAME: 08 Industrial Applications and Services
IRS NUMBER: 475386878
STATE OF INCORPORATION: DE
FISCAL YEAR END: 1231
FILING VALUES:
FORM TYPE: UPLOAD
SEC FILE NUMBER: 377-07444
BUSINESS ADDRESS:
STREET 1: 11 HUGHES
CITY: IRVINE
STATE: CA
ZIP: 92618
BUSINESS PHONE: 949-427-7785
MAIL ADDRESS:
STREET 1: 11 HUGHES
CITY: IRVINE
STATE: CA
ZIP: 92618
FORMER COMPANY:
FORMER CONFORMED NAME: Beta Bionics, Inc
DATE OF NAME CHANGE: 20160513
PUBLIC REFERENCE ACCESSION NUMBER: 0000950123-24-009228
LETTER
1
filename1.pdf
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TEXT-EXTRACT
2
filename2.txt
December 6, 2024
Sean Saint
Chief Executive Officer
Beta Bionics, Inc.
11 Hughes
Irvine, CA 92618
Re: Beta Bionics, Inc.
Amendment No. 2 to Draft Registration Statement on Form S-1
Submitted November 25, 2024
CIK No. 0001674632
Dear Sean Saint:
We have reviewed your amended draft registration statement and have the
following
comments.
Please respond to this letter by providing the requested information and
either
submitting an amended draft registration statement or publicly filing your
registration
statement on EDGAR. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why
in your
response.
After reviewing the information you provide in response to this letter
and your
amended draft registration statement or filed registration statement, we may
have additional
comments. Unless we note otherwise, any references to prior comments are to
comments in
our November 6, 2024 letter.
Amendment No. 2 to Draft Registration Statement on Form S-1
Prospectus Summary
Commercial Opportunity and Strategy, page 3
1. We note your response to comment 3, including your disclosure that you
estimate
that the current dollar value of the insulin pump market for people
with T1D in the
United States is approximately $2 billion and that the U.S.
patient population would
be valued at approximately $4 billion, assuming current users of MDI
fully converted
to pumps instead, and at current pump pricing levels. Please revise
or provide an
analysis explaining the reasonableness of the assumption that all
current users of MDI
will be fully converted to pumps in your $4 Billion Total Addressable
Market
December 6, 2024
Page 2
estimate. You state that "In the past, people with T1D have shown
willingness to
quickly adopt new technologies when the value proposition was far
superior to
previously available options" and that "CGMs have been adopted by an
estimated
70% of people with T1D in the United States." In your discussion,
further describe
your bases for this assumption in light of various factors, including
your current
competitive position and the current adoption rates.
Risk Factors
We are subject to a post-market surveillance order issued by the FDA for our
iLet. If the FDA
determines that our iLet does not perform..., page 36
2. We note your response to comment 6. Please revise your summary to
discuss the post-
market surveillance order.
We and the third parties with whom we work are subject to stringent and
evolving U.S. and
foreign laws, regulations, and rules..., page 61
3. We note your response to comment 7. Please revise to discuss whether you
have any
processes in place to safeguard sensitive information that might be used
in connection
with your algorithms, including in the future, to train potential AI/ML
models.
Development and Commercial Agreement, page 178
4. Please disclose here whether each of the development and
commercialization terms
under the related agreement is exclusive to each party. We note
disclosure on page 47
that your development agreement with DexCom provides you with
non-exclusive
licenses to integrate the currently available generation of DexCom s
iCGM
technology with the iLet.
Please contact Julie Sherman at 202-551-3640 or Jeanne Baker at
202-551-3691 if
you have questions regarding comments on the financial statements and related
matters. Please contact Juan Grana at 202-551-6034 or Lauren Nguyen at
202-551-3642 with
any other questions.
Sincerely,
Division of
Corporation Finance
Office of Industrial
Applications and
Services
cc: Carlos Ramirez, Esq.