November 6, 2024

Sean Saint
Chief Executive Officer
Beta Bionics, Inc.
11 Hughes
Irvine, CA 92618

       Re: Beta Bionics, Inc.
           Amendment No. 1 to Draft Registration Statement on Form S-1
           Submitted October 28, 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 October 10, 2024 letter.

Amendment No. 1 to Draft Registration Statement on Form S-1
Prospectus Summary, page 1

1.     We note your response to comment 3. Please revise to disclose, as stated
in your
       response to the comment letter dated October 10, 2024, that you continue
to analyze
       your expansion but do not currently have a specific timeline for your
expansion plans
       to disclose. Please also disclose the geographic market(s) where the
iLet is currently
       offered.
 November 6, 2024
Page 2
Clinical and Real-World Data Demonstrate the Safety, Effectiveness and
Simplicity of the
iLet, page 2

2.     We note your response to comment 6. Please revise to explain how GMI and
HbA1c
       are directly comparable even though they are two different indicators,
and discuss any
       material assumptions and/or risks associated with their comparison.
Commercial Opportunity and Strategy, page 3

3.     We note your response to comment 9. Please revise to further discuss the
"historical
       T1D population growth rate and public and industry data" on which you
base your
       assumption that the T1D total addressable market for insulin pumps in
the United
       States is forecasted to grow at approximately 2% per year. Please also
further discuss
       the "publicly available sales information and industry data" that you
cite to
       substantiate the total addressable markets for existing pump users and
potential new
       pump users, and discuss any assumptions relied upon when forecasting the
conversion
       of persons with T1D from syringes and/or insulin pens to insulin pumps.
Product Development Pipeline and Future Initiatives, page 4

4.     We note your response to comment 12. Please revise to further discuss
any material
       steps, including clinical testing, trials, and/or additional studies, as
       applicable, required for each of your product candidates prior to any
submissions to
       the FDA. As an example only, we note your disclosure that you "are in
the early
       stages of developing an insulin pump that is designed to adhere directly
to the skin
       and administer insulin without the need for tubing" and that you "expect
that the
       algorithm [to be used in connection with the patch pump] will need to be
studied in
       both T1D and T2D populations in order to seek clearance in both T1D and
T2D".
       Please disclose whether the patch pump will require clinical trials
prior to the FDA
       submission, and discuss the studies to be conducted in connection with
the associated
       algorithm.
The Offering, page 13

5.     We note your disclosure here and throughout the prospectus regarding
your directed
       share program. Please revise your prospectus to clarify, where
appropriate, the risks
       associated with certain participants of the directed share program not
being subject to
       a 180-day lock-up restriction. In addition, please expand your
disclosure to address
       the process that prospective participants will follow to participate in
the program, the
       manner in which you will communicate with prospective participants about
the
       program, when and how you will determine the allocation for the program,
whether
       such allocation will change depending on the interest level of potential
participants,
       and any other material features of the program.
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 35

6.     We note your response to comment 17. Please revise your summary to
discuss the
       post-market surveillance order. Please also clarify whether the FDA
expressed
       concern with the limited effectiveness data for design features specific
to the iLet.
 November 6, 2024
Page 3

We and the third parties with whom we work are subject to stringent and
evolving U.S. and
foreign laws, regulations, and rules..., page 60

7.     We note your disclosure that "[u]se of AI/ML in connection with [y]our
confidential,
       proprietary, or otherwise sensitive information, including personal data
or software
       source code, may result in leaks, disclosure, or otherwise unauthorized
or unintended
       access to such information, including if such information is used to
further refine and
       train the underlying AI/ML models" and that "AI/ML models may create
flawed,
       incomplete, or inaccurate outputs, some of which may appear
correct...[which] may
       happen if the inputs that the model relied on were inaccurate,
incomplete or flawed
       (including if a bad actor    poisons    the AI/ML with bad inputs or
logic), or if the logic
       of the AI/ML is flawed (a so-called    hallucination   )." Please revise
your regulatory
       disclosures to discuss how you train your AI/ML models, including the
processes you
       rely on to safeguard sensitive information, and how you account for
potential AI/ML
       "hallucinations" which may produce inaccurate results.
Use of Proceeds, page 93

8.     We note the disclosure elsewhere in your filing that you are developing
certain other
       products such as the patch pump in T1D and T2D and a first-of-its-kind
bihormonal
       configuration of the iLet. When available, please revise this section to
disclose your
       estimated uses of proceeds from this offering.
Business
Our Solution: The iLet Bionic Pancreas, page 137

9.     We note your response to comment 26. Please revise to address the
following points:

             Please briefly explain how the basal-rate functions and how the
basal-rate profile
           is compiled using CGM data.
             Please define insulin pharmacokinetics and discuss how the
mathematical
           formulation "for estimating current concentration of insulin in the
blood and
           predicting future concentrations" was developed.
             We note your disclosure that "[y]our adaptive meal dose insulin
algorithm
           predicts the amount of insulin that is needed for the announced meal
type and
           relative size based on the amount of insulin required for previously
announced
           meals of that type and relative size, and any additional insulin
needed is provided
           by the corrections algorithm based on CGM data." Please briefly
explain how the
           system operates when a meal is outside historical parameters.
10.    Please revise to clarify whether the iLet is compatible with third-party
infusion sets or
       insulin cartridges.
 November 6, 2024
Page 4
The iLet Bionic Pancreas Pivotal Trial (BPPT) testing the iLet in adults and
children with
T1D, page 147

11.    We note your response to comment 27. Please revise to quantify the
number of events
       due to infusion set failure in the iLet-A/L group and the number of
other device-
       related issues. Please also further discuss the episodes of
hyperglycemia with or
       without ketosis reported in the iLet-A/L group relating to the trial
device.
Management
Family Relationships and Other Arrangements, page 192

12.    We note your disclosure that certain directors were designated pursuant
to the
       amended and restated voting agreement. Please revise to disclose the
material terms of
       the amended and restated voting agreement and file the agreement as an
exhibit to the
       registration statement. Refer to Item 601(b)(10) of Regulation S-K.
Financial Statements
Note 3 - Revenue recognition, page F-13

13.    Your response to prior comment 33 does not address our request to
disaggregate
       revenues for the iLet product and single use products. Please advise. In
addition to the
       guidance in ASC 606, please also address the guidance in ASC
280-10-50-40. Please
       note that once you update your financial statements, your Management's
Discussion
       and Analysis should separately address revenues for the iLet product and
single use
       products to the extent those revenues have differing growth rates and/or
contributions
       to your gross margins. Refer to Item 303(a)(3) of Regulation S-X.
General

14.    We note your response to prior comment 34. Please revise to clarify that
the only
       models that are currently compatible with your iLet are DexCom   s G6
and G7 devices
       and Abbott   s FreeStyle Libre 3 Plus CGM sensor.
15.    We note your response to comment 35. Please revise your disclosure to
provide the
       basis for each of the below statements, including specific studies or
sources. In
       addition, to the extent that some of these statements are intended to be
qualified to
       your belief, please revise to state the basis for your belief.

             Page 2: "Currently, based on public and industry data, we believe
that
           approximately one-third of people with T1D in the United States
utilize insulin
           pumps or hybrid closed-loop systems to receive their daily insulin,
while the
           majority receive their daily insulin via MDI therapy, which is less
complex, but
           often less effective and has been shown to be associated with higher
HbA1c
           levels."
             Page 6: "Among the T2D population, approximately 1.8 million
require intensive
           insulin therapy, but fewer than 10% have adopted pump technology to
date, based
           on public and industry data."
             Page 134: "Based on data from long-term population studies,
diabetes is estimated
           to shorten overall life expectancy by 7-10 years on average."
 November 6, 2024
Page 5

       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.