SecProbe.io

October 10, 2024
Sean Saint
Chief Executive Officer
Beta Bionics, Inc.
11 Hughes
Irvine, CA 92618
Re:Beta Bionics, Inc.
Draft Registration Statement on Form S-1
Submitted September 13, 2024
CIK No. 0001674632
Dear Sean Saint:
            We have reviewed your 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.
Draft Registration Statement on Form S-1
Prospectus Summary, page 1
1.Please revise to briefly explain the hybrid closed-loop systems in contrast to your
adaptive closed-loop algorithms.
2.We note the disclosure on page 44 that the iLet is currently only compatible with
DexCom’s G6 and G7 iCGM devices and Abbott’s FreeStyle Libre 3 Plus CGM
sensor. Please revise to explain whether a CGM, such as the DexCom G7 or the
Abbott FreeStyle, is required in connection with the use of the iLet. If required, please
highlight, both in your summary and your business disclosures, that the iLet requires
the purchase and use of a third-party sensor that is not manufactured or sold by Beta
Bionics. Please also further discuss the function of these CGMs.

October 10, 2024
Page 2
3.We note your disclosure on page 1 that "[yo]ur initial commercialization efforts for
the iLet are focused on the type 1 diabetes (T1D) market." We also note your
disclosure on page 4 that "[you] are promoting sales of the iLet through an internal
sales organization, where [y]our initial direct sales efforts are focused on high volume
endocrinology practices and then, over time, the larger, but more diffuse,
multispecialty practices in primary care." Please revise to clearly disclose the markets
where the iLet is currently being offered. Please also provide a brief discussion on
timing for your proposed expansion to multispecialty practices in primary care, and to
international markets.
4.We note your disclosure on page 1 that "[t]he average hemoglobin A1C (HbA1c), a
measure of average blood-glucose (BG) levels over an extended period of time,
among adults in the United States with T1D is 8.2%, and currently only about 20% of
adults with T1D meet or exceed the American Diabetes Association (ADA) goal for
HbA1c." Please disclose the ADA goal for HbA1c.
5.We note your disclosure on page 2 regarding your net losses. Please revise to provide
a brief explanation of these net losses. Please also discuss your accumulated deficit.
Clinical and Real-World Data Demonstrate the Safety, Effectiveness and Simplicity of the
iLet, page 2
6.We note your disclosure that "[o]f the 5,190 iLet users who uploaded CGM readings
to the Beta Bionics cloud over the first year after [y]our commercial launch (May 19,
2023 to May 18, 2024), 3,300 had at least three-weeks’ worth of iLet data and a pre-
iLet baseline HbA1c value available. Data from these 3,300 users showed an overall
improvement, from an average HbA1c of 8.5% to an average glucose management
indicator (GMI)—a CGM surrogate for HbA1c—of 7.3%, which demonstrates a
clinically meaningful improvement across this much larger patient population." Please
revise to explain how the baseline data was sourced. Please also clarify how GMI is a
surrogate for HbA1c and explain how you can compare these two different measures,
HbA1c and GMI, to demonstrate "a clinically meaningful improvement".
7.We note your reference to “real-world” iLet data from 3,300 users which showed an
overall improvement in glycemic control. Please revise to describe how you
measure "clinically meaningful improvement."
We note your disclosure that "participant cohorts within important subgroups among
the overall T1D population, including adults, children, those with starting HbA1c
levels greater than 7%, those on MDI, and those on insulin pump therapy without
automation, who used the iLet also demonstrated statistically significant and clinically
relevant improvements in glycemic control versus the standard of care." Please revise
your summary disclosures to quantify this statistical significance. Please also add a
cross reference to the more fulsome disclosure regarding the BPPT starting on page
139. We also note your disclosure that results from the BPPT "stand in contrast to
those of multiple other large T1D population trials, each with thousands or tens-of-
thousands of participants, in which it has been observed that a higher frequency of
active glucose monitoring was strongly associated with a lower HbA1c level, and a
higher frequency of user-initiated corrective dosages from a sensor-augmented insulin
pen or a hybrid closed-loop system correlated strongly with improvements in the 8.

October 10, 2024
Page 3
amount of time PWD experienced BG levels within the range associated with
effective control, or time in range". Please note the studies that are being referenced
here.
Commercial Opportunity and Strategy, page 3
9.We note your disclosure on page 3 that "[t]he T1D total addressable market for insulin
pumps in the United States is estimated to be approximately $6 billion and is
forecasted to grow at approximately 2% per year (in line with overall population
growth)." We also note your disclosure that "[t]he value of the existing pump market
in the United States was estimated to be approximately $2 billion in 2023, with a
projected compound annual growth rate (CAGR) of 11% through 2027" and that
"[a]pproximately two-thirds of people with T1D in the United States do not currently
utilize a pump for insulin treatments and instead receive MDI from either a syringe or
an insulin pen...[t]his U.S. patient population, though declining at an approximate 9%
CAGR, would be valued at $4 billion if fully converted to pumps." Please revise to
substantiate each of these figures, including the $6 billion total addressable market for
T1D insulin pumps in the United States. Please also discuss any assumptions relied
upon when forecasting market growth and the conversion of persons with T1D from
syringes and/or insulin pens to insulin pumps. Finally, please clarify here, as you do
on page 10, that iLet is currently only authorized by the FDA for treatment of T1D in
adults and children six years of age or older.
10.Please revise to clarify that it is management's belief that the commercial opportunity
for the iLet in T1D is substantial.
Potential New Pump Adopters: Approximately Two-Thirds of the Total T1D Population, $4
Billion Total Addressable Market, page 3
11.We note your comparison to the DexCom G6 and its increased adoption to the
potential for the iLet to dramatically expand the reach of insulin delivery technologies
in the marketplace. Please revise to remove such disclosure or include clarifying and
balanced disclosure that DexCom is not your product and that you cannot provide any
assurance that such potential will be reached.
Product Development Pipeline and Future Initiatives, page 4
We note that you have various products currently in development, including: an
insulin pump that is designed to adhere directly to the skin and administer insulin
without the need for tubing, a bihormonal configuration of the iLet, which combines
automated delivery of insulin and glucagon, and a pump-compatible glucagon
formulation. We also note that you intend to pursue expanded use of the iLet to treat
people with insulin-dependent T2D. Please revise to discuss the current stage of
development of each of these product candidates and/or expanded indications. Please
also briefly discuss the regulatory approvals that will be required in connection with
each of these product candidates. As an example only, we note your disclosure that
"[you] expect to initiate pivotal clinical trials and seek FDA device clearance for
[y]our bihormonal configuration and, if successful, seek FDA marketing authorization
for this configuration, as well as FDA approval for a pump-compatible formulation
of glucagon for chronic usage." Please clarify the timing for initiation of the pivotal 12.

October 10, 2024
Page 4
clinical trials and the FDA submission, as well as the applicable FDA regulatory
pathway that you are contemplating for marketing authorization and clearance.
Finally, please also update your risk factor disclosures, including on page 30, and your
business disclosures, accordingly.
Our Strengths, page 7
13.We note the disclosure that your technology is supported by an extensive intellectual
property portfolio, which includes patents, know-how, trade secrets and licenses from
the Trustees of Boston University and Xeris. Please revise to briefly discuss the
material terms of these license agreements.
Risk Factors
The market opportunities for our iLet for the treatment of diabetes may be smaller than we
anticipated., page 22
14.We note your disclosure that "[e]ven though [you] have obtained a significant market
share for [y]our iLet, because the potential target populations could be smaller than
[you] expect, [you] may never achieve profitability without obtaining regulatory
clearance for the iLet in additional indications." Please revise to explicitly note that
iLet does not currently have regulatory approval for T2D. Please also discuss the
current market share for iLet.
Competing products, therapeutic techniques or other technological developments and
breakthroughs for the monitoring, treatment..., page 23
15.We note your disclosure that "[you] have designed [y]our hardware products to
resemble modern consumer electronic devices to address certain functionality
concerns consumers have raised with respect to traditional pumps." Please revise to
briefly discuss these functionality concerns to provide context for your disclosure.
Our results of operations will be harmed if we are unable to accurately forecast customer
demand for our products and manage our inventory., page 23
16.We note your disclosure that "in the first 12 months after the release of the iLet, [you]
faced demands that exceeded [y]our existing supply of the iLet, which resulted in
backorders." Please briefly discuss these demands, and explain whether the resulting
backorders materially impacted your results of operations. Please also explain whether
and how you have undertaken efforts to mitigate the potential impact of an increase of
demand on your manufacturing capacity.

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 32
We note your disclosure that the FDA has notified you that the iLet is subject to a
mandatory post-market surveillance order under Section 522 of the FDCA, which
authorizes the FDA to require a manufacturer to conduct post-market surveillance for
devices that meet certain criteria and that "the FDA determined that the failure of the
iLet would be reasonably likely to have serious adverse health consequences". Please
revise your summary to discuss this post-market surveillance order. We also note your 17.

October 10, 2024
Page 5
disclosure that "[t]he FDA issued this 522 Order based on its concerns with the
limited safety and effectiveness data for the iLet Dosing Decision Software in certain
intended use populations, incidence rates of rare adverse events associated with device
use, and the limited safety and effectiveness data for specific design features (i.e., lack
of conventional open-loop mode, the BG-run feature, body weight only initialization,
handling of unannounced meals, and use of lower and higher glucose targets for the
device)." Please revise to explain each of the rare adverse events and discuss the
incidence rates. Please also revise the risk factor disclosure on page 37 to discuss
adverse events and the rates of severe hypoglycemia and DKA associated with iLet.
Management's Discussion And Analysis Of Financial Condition And Results Of Operations
Overview, page 95
18.We note your disclosure that "[you] are also optimizing [y]our direct sales efforts by
growing, in parallel, an internal customer support team. All of this has been
supplemented with strategic marketing initiatives and a targeted campaign [you] call
the “Bionic Universe,” which is built around a community of iLet users, caregivers,
and key opinion leaders (KOLs) who share their stories to inspire others." Please
revise to discuss the markets where Bionic Universe is currently operating. Please also
provide additional detail regarding how you educate your potential and current users
regarding the operation of the iLet.
19.You disclose that in addition to the iLet, you sell single-use products that are used
together with the iLet, including cartridges for storing and delivering insulin, as well
as infusion sets that connect the insulin pump to a user’s body. Please revise to briefly
discuss these single-use products including the cartridges for storing and delivering
insulin and infusion sets. Also clarify whether the single-use products are sold with
the initial sale of the iLet.
License and Collaboration Agreements, page 97
20.Please revise your disclosures in this section regarding the license and collaboration
agreements to discuss the various regulatory milestones that you are required to meet.
As an example only, we note your disclosure on page 98 regarding the device license
agreement with Boston University that "[you] have satisfied all the milestones set
forth under the Device License Agreement required to be achieved to date, with
specified regulatory milestones remaining to be achieved in connection with [y]our
development of the Licensed Products and Licensed Processes." Please also ensure
that you have disclosed material commercial terms applicable to each agreement,
including your commercialization agreements with DexCom and Abbott Diabetes
Care.
Key Factors Affecting Our Performance, page 103
21.We note your disclosure on page 105 that "[yo]ur costs are subject to fluctuation, and
[you] continue to evaluate contributing factors, specifically those leading to
inflationary cost increases in logistics, price of raw materials, cost of labor,
transportation and operating supplies." Please revise to discuss, either here or
elsewhere in your registration statement, the source of the raw materials used in your
products. Refer to Item 101(h) of Regulation S-K.

October 10, 2024
Page 6
Results of Operations
Research and Development Expenses, page 109
22.We note the significance of your research and development expenses. Please revise
future filings to provide more detail for your research and development expenses for
each period presented, including but not limited to by product candidate as well as by
the nature of the expenses. To the extent that you do not track expenses by product
candidate, please disclose as such.
23.We note that research and development expenses were $31.4 million for the year
ended December 31, 2022, compared to $17.9 million for the year ended
December 31, 2023 and that the decrease of $13.5 million was primarily attributable
to a $12.3 million decrease in research and development activities and associated
spend as a result of the commercialization of the iLet in May 2023 and the remaining
$1.2 million decrease was attributable to a decrease in payroll and payroll related
expenses associated with a reduction in headcount. Please revise to explain why your
research and development activities decreased in connection with the
commercialization of the iLet in May 2023. Please also briefly discuss the reduction
in headcount.
Critical Accounting Policies and Estimates
Determination of Fair Value of Our Class B Common Stock and Se