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Correspondence 0001104659-24-081198 from Baird Medical Investment Holdings Ltd (BDMD) (CIK 0001982444) (BDMD)

Baird Medical Investment Holdings Ltd (BDMD) (CIK 0001982444)
Date: July 19, 2024 · CIK: 0001982444 · Accession: 0001104659-24-081198

AI Filing Summary & Sentiment

File numbers found in text: 333-274114

Referenced dates: July 8, 2024

Date
July 19, 2024
Author
Not clearly detected
Form
CORRESP
Company
Baird Medical Investment Holdings Ltd (BDMD) (CIK 0001982444)

Letter

VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Industrial Applications and Services Re: Baird Medical Investment Holdings Limited Amendment No. 4 to Registration Statement on Form F-4 Filed June 20, 2024 File No. 333-274114

Dear Mr. Newberry:

This letter is in response to the comments of the staff of the United States Securities and Exchange Commission (the “Staff”) contained in your letter dated July 8, 2024 (the “Comment Letter”), regarding Amendment No. 4 to Registration Statement on Form F-4 (the “Registration Statement”), which was filed by Baird Medical Investment Holdings Limited (the “Company”) with the United States Securities and Exchange Commission (the “Commission”) on June 20, 2024.

The Company has filed today Amendment No. 5 to the Registration Statement (“Amendment No. 5”) together with this letter via EDGAR correspondence. For the convenience of the Staff, the numbering of the paragraphs below corresponds to the numbering of the comment in the Comment Letter, the text of which the Company has incorporated into this response letter in italicized type, and which is followed by the Company’s response. Unless otherwise indicated, all page references in the responses are to page numbers in Amendment No. 5. Capitalized terms used herein but not defined shall have the meanings ascribed to them in Amendment No. 5.

Amendment No. 4 to Form F-4 Filed June 20,

Unaudited Pro Forma Condensed Combined Financial Information, page 71

1. Comment: We note your response to comment 2. Adjustment (b)(b) states that it is for the reversal of non-recurring fees. Please specify what non-recurring fees are being reversed in this adjustment. We remind you of the updated guidance in Article 11-02(a)(6) of Regulation S-X and Section II.D of SEC Release 33-10786 which includes guidance regarding the inclusion of transaction accounting adjustments for nonrecurring items. Please advise or revise as necessary.

Response: The Company acknowledges the Staff’s comment and has revised the disclosure on page 82 of Amendment No. 5 in response to the Staff’s comment, to eliminate the Adjustment (bb).

2. Comment: Prior to Closing, Baird Medical will transfer 1,947,058 PubCo Ordinary Shares to Newco and the Minority Holders will exchange their ownership interests in Baird Medical for all of the outstanding ownership interests in Newco; and after the special meeting, Merger Sub 2 will merge with and into Newco, with Newco continuing as the surviving entity and wholly-owned subsidiary of PubCo. This transaction is referred to as the Second Merger in your filing. Please expand your disclosures to address the business purpose of the Second Merger and tell us what consideration was given to separately reflecting the Second Merger in the pro forma information provided, including whether noncontrolling interests need to be presented pursuant to ASC 810.

Response: The Company acknowledges the Staff’s comment and has revised the disclosure on the cover page and pages 21, 45, 59 and 172 of Amendment No. 5 in response to the Staff’s comment to clarify that the business purpose of the Second Merger is both to ensure compliance with Nasdaq’s public float requirement as well as to facilitate that additional PubCo shares are held after closing by shareholders most likely to be long-term holders. The Second Merger contemplates that prior to Closing, Baird Medical will transfer 1,947,058 PubCo Ordinary Shares to Newco and the Minority Holders will exchange their ownership interests in Baird Medical for all of the outstanding ownership interests in Newco. Then, at closing and pursuant to the Second Merger, these 1,947,058 PubCo Ordinary Shares issued to Newco will be cancelled and an equal number will be issued to the Minority Holders. Consequently, the number of PubCo Ordinary Shares outstanding before and after the transaction will not be affected by the Second Merger. As such, the shares held by the Minority Holders will be of the PubCo and not a subsidiary of PubCo. So, there is no non-controlling interest in a subsidiary related to the Minority Holders that requires consideration under ASC 810. Additional language has been added to pages 72 and 78 of Amendment No. 5 describing the two mergers.

Comparative Share Information, page 82

3. Comment: We note your response to comment 6. Certain pro forma per share amounts presented in your comparative share information table do not appear to be the same as the amounts as presented in your pro forma financial information beginning on page 71. Specifically the pro forma net income (loss) per share–basic and diluted amounts appear to be different. Please revise as necessary.

Response: The Company acknowledges the Staff’s comment and has revised the disclosure on page 83 of Amendment No. 5 in response to the Staff’s comment to make the pro forma share amounts consistent.

Background of the Business Combination, page

4. Comment: We note your revised disclosure in response to prior comment 9. With respect to the refined projections discussed in the third bullet point, please expand your disclosure to explain the impact of the revised projections on R&D and depreciation.

Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 197 and 198 of Amendment No. 5 in response to the Staff’s comment.

5. Comment: We note your revised disclosure relating to the multi-year trend analysis of hospital usage in response to prior comment 10, which we reissue in part. You disclose that Baird Medical management estimated the revised 2024 needles sales to be increased to 60,142, assuming a 13.7% year-over-year estimated hospital usage growth and increased year-end inventory from 1.6 months to 1.9 months at hospitals and distributors at the end of 2024. Please expand your disclosure to provide a reasonable basis for Baird Medical management’s estimates for a 13.7% year-over-year hospital usage growth and increased year-end inventory in light of the preliminary 2023 results.

Response: The Company acknowledges the Staff’s comment and has revised the disclosure on page 214 of Amendment No. 5 in response to the Staff’s comment.

Opinion of Financial Advisor to the ExcelFin Board, page 213

6. Comment: We note your response to prior comment 13 and your revised disclosure removing the references to “projected US revenue for Baird Medical for the calendar years ended 2024 through 2030” and “US Market Development Update for Baird Medical, dated February 2024.” Please advise whether the financial advisor will be providing an updated and revised fairness opinion.

Response: The Company acknowledges the Staff’s comment and respectfully notes that, as noted in the Company’s response to prior comment 13, Houlihan Capital, LLC has revised its fairness opinion to remove references to projected U.S. revenue for Baird Medical for the calendar years ended 2024 through 2030 and the U.S. Market Development Update for Baird Medical. The updated fairness opinion is dated the same date as the original date (March 8, 2024) and was included in Annex D of Amendment No. 4.

ExcelFin’s Management's Discussion and Analysis, page 258

7. Comment: Please continue to provide the results of operations discussion for the two years ended December 31, 2023 in your filing. Refer to Item 5 of the Form 20-F.

Response: The Company acknowledges the Staff’s comment and has revised the disclosure on page 262 of Amendment No. 5 in response to the Staff’s comment to include the results of operations discussion for the two years ended December 31, 2023.

Customers, page 287

8. Comment: We note your revised disclosure on page 287 that one distributor accounted for 10.4% of Baird Medical’s total revenue for the year ended December 31, 2023. Please identify this top customer and provide a brief description of the material terms of your agreement with such customer, such as the termination provision and whether there are any minimum purchase requirements. If material, please also file the agreements as exhibits to the registration statement as required by Item 21 to Form F-4 and Item 601(b)(10) of Regulation S-K, or explain to us why you believe you are not required to do so.

Response: The Company acknowledges the Staff’s comment and has provided a brief description of the material terms of the Company’s agreement with such customer (the “Top Distributor”), including the termination provision and whether there are any minimum purchase requirements, on page 290 of Amendment No. 5. The Company respectfully notes that the identity of the Top Distributor is customarily and actually treated as private and confidential and such information is not material. The Company is subject to a non-disclosure agreement with the Top Distributor, and disclosure of the customer’s identity, the pricing of the medical devices which are sold to the Top Distributor, and the identity and location of the Top Distributor’s hospital clients would lead to competitors of the Company maliciously competing for the customer’s business.

Nonetheless, the Company has filed the agreement as Exhibit 99.9 to the registration statement, but to address confidentiality concerns and protect sensitive business information, the name of the Top Distributor, the pricing of the medical devices to be sold, and the identity and location of the Top Distributor’s hospital clients have been redacted in the filed agreement. The key terms of the filed agreement (the “Top Distributor Agreement”) include: (i) the Top Distributor is authorized to sell microwave ablation therapeutic apparatuses and MWA needles to listed hospitals and assumes inventory risk, as products with quality issues can be exchanged but not otherwise returned; (ii) the Top Distributor determines the selling prices and can exchange faulty products, but the Company has not received any requests for returns for the years ended December 31, 2022 and 2023, and the Company does not accept returns for non-quality-related issues; (iii) control of the goods transfers to the Top Distributor upon delivery and acceptance; and (iv) the Top Distributor shall meet a minimum purchase requirement of two hundred MWA needles per fiscal year quarter. For the year ended December 31, 2023, the Top Distributor had met its minimum purchase requirement based on the Company's annual review of the Top Distributor's number of sales.

The Top Distributor Agreement may be terminated in a number of circumstances: (i) the Top Distributor commits fraud, bribery or other acts which violate PRC laws; (ii) the Top Distributor is unable to meet its minimum purchase requirement; (iii) the Top Distributor engages in sales of medical devices from the Company’s competitors which are similar to the Company’s own medical devices or products; (iv) fines or penalties incurred by the Top Distributor in accordance with the terms of the Top Distributor Agreement are not paid to the Company by the stipulated deadline; or (v) the Top Distributor fails to pay for the microwave ablation therapeutic apparatuses and/or MWA needles it purchases from the Company after fifteen days following the payment due date. Based on the Company's annual review of the Top Distributor for the year ended December 3 1, 2023, the Top Distributor had not breached any of the provisions of the Top Distributor Agreement which may warrant the termination of the Top Distributor Agreement.

Research and Development - Clinical Trials, page 297

9. Comment: We note your revised disclosure in response to prior comment 14, which we reissue in part. We refer to your disclosure on page 303 that you plan to have the clinical testing plan program for your breast lump clinical trials and finalize the applicable research proposal for your pulmonary nodule clinical trials by the end of June 2024. Please revise to update your disclosure in regard to these recent developments accordingly.

Response: The Company acknowledges the Staff’s comment and has revised the disclosures on pages 275, 276, 278, 305 to 306, 308 and 342 of Amendment No. 5 in response to the Staff’s comment.

Revenues, page 342

10. Comment: Please disclose why revenues from Direct customers decreased whereas revenue from Distributors increased (page F-34). Disclose also whether you are aware of a material amount of unsold inventory held by your Distributors. In this regard, we note the Distributor inventory reports referenced on page 102. Tell us the dollar amount of inventory held by Distributors at December 31, 2023.

Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 103, 213 to 214 and 346 of Amendment No. 5.

The primary drivers of decreased revenue from direct customers were: (i) in 2023, the Company upgraded its certification for MWA needles in China from Class II products to Class III products, which resulted in a delay in several provinces while the Company re-registered its products, thus negatively affecting the revenue from direct customers; and (ii) for the year ended December 31, 2023, revenue from sales of other medical devices decreased due to such sales being derived from non-recurring orders from time-to-time. In 2022, the Company received a few large orders of other medical devices, while no such orders were received in 2023, resulting in a significant decrease in 2023 as compared to 2022.

The primary reason for the increase in revenue from distributors was that, for the year ended December 31, 2023, revenue from sales of MWA therapeutic apparatuses increased significantly. This notable surge in revenue was primarily attributed to a strategic adjustment in unit prices and an increase in sales orders. Previously, in 2022, as part of the Company’s vigorous equipment promotion efforts, the Company sold those MWA therapeutic apparatuses at discounted prices. However, as customers sought additional equipment beyond the Company’s offerings, the Company transitioned away from the previously discounted prices. The transition away from the previously discounted prices resulted in increased revenue from distributors.

The Company respectfully notes that, despite the existence of distributor inventory reports, the Company does not have accurate data which could allow the Company to pinpoint the dollar amount of inventory held by the Company’s distributors as of December 31, 2023. As revised on pages 103, 213 and 214 of Amendment No. 5, although the Company’s deliverers and distributors are obligated by contract to provide monthly reports, the Company has not enforced this contractual right in order to maintain a positive working relationship with such parties and protect the sensitive business information contained in such data.

Further, since the Company does not have full visibility of the business operations of its deliverers and distributors, it is unable to verify such inventory reports when provided by deliverers and distributors. Therefore, the Company mainly relies on its own monthly reports based on its own due diligence, communication with deliverers and distributors, and industry know-how to track the estimated inventory levels of its microwave ablation medical devices held by its deliverers and distributors and predict the sales trends of such devices. Based on such arrangement, the Company is not aware of any material amount of unsold inventory held by its distributors. However, the Company is unable to provide assurance that the information contained in the Company’s monthly reports, or the monthly reports provided by the deliverers and distributors, is accurate.

Selling and marketing expenses, page 344

11. Comment: We note your disclosure that selling and marketing expenses decreased by $1 million in the fiscal yea

Show Raw Text
CORRESP
1
filename1.htm

July 19, 2024

VIA EDGAR

Tracey Houser

Jeanne Baker

Conlon Danberg

Lauren Nguyen

United States Securities and Exchange Commission

Division of Corporation Finance

Office of Industrial Applications and Services

100 F Street, N.E.

Washington, D.C. 20549

    Re:
    Baird Medical Investment Holdings Limited

    Amendment No. 4 to Registration Statement on Form F-4

    Filed June 20, 2024

    File No. 333-274114

Dear Mr. Newberry:

This letter is in response
to the comments of the staff of the United States Securities and Exchange Commission (the “Staff”) contained in your
letter dated July 8, 2024 (the “Comment Letter”), regarding Amendment No. 4 to Registration Statement on Form F-4
(the “Registration Statement”), which was filed by Baird Medical Investment Holdings Limited (the “Company”)
with the United States Securities and Exchange Commission (the “Commission”) on June 20, 2024.

The Company has filed today
Amendment No. 5 to the Registration Statement (“Amendment No. 5”) together with this letter via EDGAR correspondence.
For the convenience of the Staff, the numbering of the paragraphs below corresponds to the numbering of the comment in the Comment Letter,
the text of which the Company has incorporated into this response letter in italicized type, and which is followed by the Company’s
response. Unless otherwise indicated, all page references in the responses are to page numbers in Amendment No. 5. Capitalized
terms used herein but not defined shall have the meanings ascribed to them in Amendment No. 5.

Amendment No. 4 to Form F-4 Filed June 20,
2024

Unaudited Pro Forma Condensed Combined Financial
Information, page 71

1. Comment: We note your response to comment 2. Adjustment (b)(b) states that it is for the reversal
of non-recurring fees. Please specify what non-recurring fees are being reversed in this adjustment. We remind you of the updated guidance
in Article 11-02(a)(6) of Regulation S-X and Section II.D of SEC Release 33-10786 which includes guidance regarding the inclusion of transaction
accounting adjustments for nonrecurring items. Please advise or revise as necessary.

Response: The
Company acknowledges the Staff’s comment and has revised the disclosure on page 82 of Amendment No. 5 in response to the Staff’s
comment, to eliminate the Adjustment (bb).

2. Comment: Prior to Closing, Baird Medical will transfer 1,947,058 PubCo Ordinary Shares to Newco
and the Minority Holders will exchange their ownership interests in Baird Medical for all of the outstanding ownership interests in Newco;
and after the special meeting, Merger Sub 2 will merge with and into Newco, with Newco continuing as the surviving entity and wholly-owned
subsidiary of PubCo. This transaction is referred to as the Second Merger in your filing. Please expand your disclosures to address the
business purpose of the Second Merger and tell us what consideration was given to separately reflecting the Second Merger in the pro forma
information provided, including whether noncontrolling interests need to be presented pursuant to ASC 810.

Response: The
Company acknowledges the Staff’s comment and has revised the disclosure on the cover page and pages 21, 45, 59 and 172 of Amendment
No. 5 in response to the Staff’s comment to clarify that the business purpose of the Second Merger is both to ensure compliance
with Nasdaq’s public float requirement as well as to facilitate that additional PubCo shares are held after closing by shareholders
most likely to be long-term holders. The Second Merger contemplates that prior to Closing, Baird Medical will transfer 1,947,058 PubCo
Ordinary Shares to Newco and the Minority Holders will exchange their ownership interests in Baird Medical for all of the outstanding
ownership interests in Newco. Then, at closing and pursuant to the Second Merger, these 1,947,058 PubCo Ordinary Shares issued to Newco
will be cancelled and an equal number will be issued to the Minority Holders. Consequently, the number of PubCo Ordinary Shares outstanding
before and after the transaction will not be affected by the Second Merger. As such, the shares held by the Minority Holders will be of
the PubCo and not a subsidiary of PubCo. So, there is no non-controlling interest in a subsidiary related to the Minority Holders that
requires consideration under ASC 810. Additional language has been added to pages 72 and 78 of Amendment No. 5 describing the two mergers.

Comparative Share Information, page 82

3. Comment: We note your response to comment 6. Certain pro forma per share amounts presented in your
comparative share information table do not appear to be the same as the amounts as presented in your pro forma financial information beginning
on page 71. Specifically the pro forma net income (loss) per share–basic and diluted amounts appear to be different. Please revise
as necessary.

Response: The
Company acknowledges the Staff’s comment and has revised the disclosure on page 83 of Amendment No. 5 in response to the Staff’s
comment to make the pro forma share amounts consistent.

Background of the Business Combination, page
188

4. Comment: We note your revised disclosure in response to prior comment 9. With respect to the refined
projections discussed in the third bullet point, please expand your disclosure to explain the impact of the revised projections on R&D
and depreciation.

Response: The
Company acknowledges the Staff’s comment and has revised the disclosure on pages 197 and 198 of Amendment No. 5 in response to the
Staff’s comment.

5. Comment: We note your revised disclosure relating to the multi-year trend analysis of hospital
usage in response to prior comment 10, which we reissue in part. You disclose that Baird Medical management estimated the revised 2024
needles sales to be increased to 60,142, assuming a 13.7% year-over-year estimated hospital usage growth and increased year-end inventory
from 1.6 months to 1.9 months at hospitals and distributors at the end of 2024. Please expand your disclosure to provide a reasonable
basis for Baird Medical management’s estimates for a 13.7% year-over-year hospital usage growth and increased year-end inventory
in light of the preliminary 2023 results.

Response: The
Company acknowledges the Staff’s comment and has revised the disclosure on page 214 of Amendment No. 5 in response to the Staff’s
comment.

Opinion of Financial Advisor to the ExcelFin
Board, page 213

6. Comment: We note your response to prior comment 13 and your revised disclosure removing the references
to “projected US revenue for Baird Medical for the calendar years ended 2024 through 2030” and “US Market Development
Update for Baird Medical, dated February 2024.” Please advise whether the financial advisor will be providing an updated and revised
fairness opinion.

Response:
The Company acknowledges the Staff’s comment and respectfully notes that, as noted in the Company’s response to prior
comment 13, Houlihan Capital, LLC has revised its fairness opinion to remove references to projected U.S. revenue for Baird Medical
for the calendar years ended 2024 through 2030 and the U.S. Market Development Update for Baird Medical. The updated fairness
opinion is dated the same date as the original date (March 8, 2024) and was included in Annex D of Amendment No. 4.

ExcelFin’s Management's Discussion and
Analysis, page 258

7. Comment: Please continue to provide the results of operations discussion for the two years ended
December 31, 2023 in your filing. Refer to Item 5 of the Form 20-F.

Response: The
Company acknowledges the Staff’s comment and has revised the disclosure on page 262 of Amendment No. 5 in response to the Staff’s
comment to include the results of operations discussion for the two years ended December 31, 2023.

Customers, page 287

8. Comment: We note your revised disclosure on page 287 that one distributor accounted for 10.4% of
Baird Medical’s total revenue for the year ended December 31, 2023. Please identify this top customer and provide a brief description
of the material terms of your agreement with such customer, such as the termination provision and whether there are any minimum purchase
requirements. If material, please also file the agreements as exhibits to the registration statement as required by Item 21 to Form F-4
and Item 601(b)(10) of Regulation S-K, or explain to us why you believe you are not required to do so.

Response: The
Company acknowledges the Staff’s comment and has provided a brief description of the material terms of the Company’s agreement
with such customer (the “Top Distributor”), including the termination provision and whether there are any minimum purchase
requirements, on page 290 of Amendment No. 5. The Company respectfully notes that the identity of the Top Distributor is customarily and
actually treated as private and confidential and such information is not material. The Company is subject to a non-disclosure agreement
with the Top Distributor, and disclosure of the customer’s identity, the pricing of the medical devices which are sold to the Top
Distributor, and the identity and location of the Top Distributor’s hospital clients would lead to competitors of the Company maliciously
competing for the customer’s business.

Nonetheless, the Company
has filed the agreement as Exhibit 99.9 to the registration statement, but to address confidentiality concerns and protect sensitive business
information, the name of the Top Distributor, the pricing of the medical devices to be sold, and the identity and location of the Top
Distributor’s hospital clients have been redacted in the filed agreement. The key terms of the filed agreement (the “Top
Distributor Agreement”) include: (i) the Top Distributor is authorized to sell microwave ablation therapeutic apparatuses and
MWA needles to listed hospitals and assumes inventory risk, as products with quality issues can be exchanged but not otherwise returned;
(ii) the Top Distributor determines the selling prices and can exchange faulty products, but the Company has not received any requests
for returns for the years ended December 31, 2022 and 2023, and the Company does not accept returns for non-quality-related issues; (iii)
control of the goods transfers to the Top Distributor upon delivery and acceptance; and (iv) the Top Distributor shall meet a minimum
purchase requirement of two hundred MWA needles per fiscal year quarter. For the year ended December 31, 2023, the Top Distributor had
met its minimum purchase requirement based on the Company's annual review of the Top Distributor's number of sales.

The Top Distributor
Agreement may be terminated in a number of circumstances: (i) the Top Distributor commits fraud, bribery or other acts which violate PRC
laws; (ii) the Top Distributor is unable to meet its minimum purchase requirement; (iii) the Top Distributor engages in sales of medical
devices from the Company’s competitors which are similar to the Company’s own medical devices or products; (iv) fines or penalties
incurred by the Top Distributor in accordance with the terms of the Top Distributor Agreement are not paid to the Company by the stipulated
deadline; or (v) the Top Distributor fails to pay for the microwave ablation therapeutic apparatuses and/or MWA needles it purchases from
the Company after fifteen days following the payment due date. Based on the Company's annual review of the Top Distributor for the year
ended December 3 1, 2023, the Top Distributor had not breached any of the provisions of the Top Distributor Agreement which may warrant
the termination of the Top Distributor Agreement.

Research and Development
- Clinical Trials, page 297

9. Comment: We note your revised disclosure in response to prior comment 14, which we reissue in part.
We refer to your disclosure on page 303 that you plan to have the clinical testing plan program for your breast lump clinical trials and
finalize the applicable research proposal for your pulmonary nodule clinical trials by the end of June 2024. Please revise to update your
disclosure in regard to these recent developments accordingly.

Response: The
Company acknowledges the Staff’s comment and has revised the disclosures on pages 275, 276, 278, 305 to 306, 308 and 342 of Amendment
No. 5 in response to the Staff’s comment.

Revenues, page 342

10. Comment: Please disclose why revenues from Direct customers decreased whereas revenue from Distributors
increased (page F-34). Disclose also whether you are aware of a material amount of unsold inventory held by your Distributors. In this
regard, we note the Distributor inventory reports referenced on page 102. Tell us the dollar amount of inventory held by Distributors
at December 31, 2023.

Response: The Company
acknowledges the Staff’s comment and has revised the disclosure on pages 103, 213 to 214 and 346 of Amendment No. 5.

The primary drivers
of decreased revenue from direct customers were: (i) in 2023, the Company upgraded its certification for MWA needles in China from Class
II products to Class III products, which resulted in a delay in several provinces while the Company re-registered its products, thus negatively
affecting the revenue from direct customers; and (ii) for the year ended December 31, 2023, revenue from sales of other medical devices
decreased due to such sales being derived from non-recurring orders from time-to-time. In 2022, the Company received a few large orders
of other medical devices, while no such orders were received in 2023, resulting in a significant decrease in 2023 as compared to 2022.

The primary reason
for the increase in revenue from distributors was that, for the year ended December 31, 2023, revenue from sales of MWA therapeutic apparatuses
increased significantly. This notable surge in revenue was primarily attributed to a strategic adjustment in unit prices and an increase
in sales orders. Previously, in 2022, as part of the Company’s vigorous equipment promotion efforts, the Company sold those MWA
therapeutic apparatuses at discounted prices. However, as customers sought additional equipment beyond the Company’s offerings,
the Company transitioned away from the previously discounted prices. The transition away from the previously discounted prices resulted
in increased revenue from distributors.

The Company respectfully
notes that, despite the existence of distributor inventory reports, the Company does not have accurate data which could allow the Company
to pinpoint the dollar amount of inventory held by the Company’s distributors as of December 31, 2023. As revised on pages 103,
213 and 214 of Amendment No. 5, although the Company’s deliverers and distributors are obligated by contract to provide monthly
reports, the Company has not enforced this contractual right in order to maintain a positive working relationship with such parties and
protect the sensitive business information contained in such data.

Further, since the
Company does not have full visibility of the business operations of its deliverers and distributors, it is unable to verify such inventory
reports when provided by deliverers and distributors. Therefore, the Company mainly relies on its own monthly reports based on its own
due diligence, communication with deliverers and distributors, and industry know-how to track the estimated inventory levels of its microwave
ablation medical devices held by its deliverers and distributors and predict the sales trends of such devices. Based on such arrangement,
the Company is not aware of any material amount of unsold inventory held by its distributors. However, the Company is unable to provide
assurance that the information contained in the Company’s monthly reports, or the monthly reports provided by the deliverers and
distributors, is accurate.

Selling and marketing expenses, page 344

11. Comment: We note your disclosure that selling and marketing expenses decreased by $1 million in
the fiscal yea