Trial Outcomes & Findings for Study of the BIOPIN 6 Naltrexone Implant in Healthy Adults (NCT NCT06216132)

Last Updated: 2026-04-28

Results Overview

Maximum observed plasma concentration (Cmax) of 6-β-naltrexol following implant placement.\[ng/ml\]. Plasma concentrations below the lower limit of quantification (LLOQ) were represented as 0 in the reported results; therefore, 0 values do not represent placeholder entries.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

16 participants

Primary outcome timeframe

Predose and 1, 3, 6, 12, 24, 48, and 72 hours post-implant; Days 7 and 10; Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 post-implant; Week 12 pre-explant and 1, 3, 6, 12, 24, 48, 72, and 96 hours post-explant; and Week 14 (Day 98).

Results posted on

2026-04-28

Participant Flow

Healthy adult volunteers were recruited at a single U.S. clinical research site (JBR Clinical Research, Salt Lake City, UT) between June 2024 and January 2025.

Participants provided informed consent and underwent screening including medical history, physical exam, laboratory testing, ECG, urine drug screen, infectious disease testing, pregnancy testing (if applicable), and naloxone challenge to confirm absence of opioid dependence. Eligible subjects were randomized to receive BIOPIN 6 implant (4.8 g or 9.6 g) or placebo implant.

Participant milestones

Participant milestones
Measure	BIOPIN 6 - 4.8 g Implant Single BIOPIN 6 implant containing 4.8 g naltrexone surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.	BIOPIN 6 - 9.6 g Implant Two BIOPIN 6 implants containing a total of 9.6 g naltrexone surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.	Placebo Implant Placebo implant composed of polymer without naltrexone, surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.
Overall Study STARTED	6	6	4
Overall Study COMPLETED	6	6	4
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the BIOPIN 6 Naltrexone Implant in Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BIOPIN 6 - 4.8 g Implant n=6 Participants Single BIOPIN 6 implant containing 4.8 g naltrexone surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.	BIOPIN 6 - 9.6 g Implant n=6 Participants Two BIOPIN 6 implants containing a total of 9.6 g naltrexone surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.	Placebo Implant n=4 Participants Placebo implant composed of polymer without naltrexone, surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.	Total n=16 Participants Total of all reporting groups
Age, Continuous	34 Years STANDARD_DEVIATION 4.24 • n=9 Participants	30 Years STANDARD_DEVIATION 2.5 • n=24 Participants	36.5 Years STANDARD_DEVIATION 11 • n=23 Participants	32.5 Years STANDARD_DEVIATION 6.2 • n=73 Participants
Sex: Female, Male Female	4 Participants n=9 Participants	2 Participants n=24 Participants	4 Participants n=23 Participants	10 Participants n=73 Participants
Sex: Female, Male Male	2 Participants n=9 Participants	4 Participants n=24 Participants	0 Participants n=23 Participants	6 Participants n=73 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=24 Participants	0 Participants n=23 Participants	0 Participants n=73 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants	0 Participants n=24 Participants	0 Participants n=23 Participants	0 Participants n=73 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=24 Participants	0 Participants n=23 Participants	0 Participants n=73 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants	0 Participants n=24 Participants	0 Participants n=23 Participants	0 Participants n=73 Participants
Race (NIH/OMB) White	6 Participants n=9 Participants	5 Participants n=24 Participants	4 Participants n=23 Participants	15 Participants n=73 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=24 Participants	0 Participants n=23 Participants	0 Participants n=73 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	1 Participants n=24 Participants	0 Participants n=23 Participants	1 Participants n=73 Participants
BMI	26.78 kg/m² STANDARD_DEVIATION 3.65 • n=9 Participants	29.92 kg/m² STANDARD_DEVIATION 2.24 • n=24 Participants	27.40 kg/m² STANDARD_DEVIATION 3.60 • n=23 Participants	28.11 kg/m² STANDARD_DEVIATION 3.29 • n=73 Participants

PRIMARY outcome

Timeframe: Predose and 1, 3, 6, 12, 24, 48, and 72 hours post-implant; Days 7 and 10; Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 post-implant; Week 12 pre-explant and 1, 3, 6, 12, 24, 48, 72, and 96 hours post-explant; and Week 14 (Day 98).

Area under the plasma naltrexone concentration-time curve (AUC) from implant placement through Day 98, calculated using noncompartmental pharmacokinetic methods based on serial plasma concentration measurements. Plasma concentrations below the lower limit of quantification (LLOQ) were represented as 0 in the reported results; therefore, 0 values do not represent placeholder entries.

Outcome measures

Outcome measures
Measure	BIOPIN 6 - 4.8 g Implant n=6 Participants Single BIOPIN 6 implant containing 4.8 g naltrexone surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.	BIOPIN 6 - 9.6 g Implant n=6 Participants Two BIOPIN 6 implants containing a total of 9.6 g naltrexone surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.	Placebo Implant n=4 Participants Placebo implant composed of polymer without naltrexone, surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.
Naltrexone Plasma Concentration Area Under the Curve (AUC₀-Day 98)	11,556 ng·hr/mL Standard Deviation 4,846	20,817 ng·hr/mL Standard Deviation 6,702	NA ng·hr/mL Standard Deviation NA Data were below the lower limit of quantification

PRIMARY outcome

Naltrexone Peak Plasma Concentration (Cmax) \[ng/ml\]. Plasma concentrations below the lower limit of quantification (LLOQ) were represented as 0 in the reported results; therefore, 0 values do not represent placeholder entries.

Outcome measures

Outcome measures
Measure	BIOPIN 6 - 4.8 g Implant n=6 Participants Single BIOPIN 6 implant containing 4.8 g naltrexone surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.	BIOPIN 6 - 9.6 g Implant n=6 Participants Two BIOPIN 6 implants containing a total of 9.6 g naltrexone surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.	Placebo Implant n=4 Participants Placebo implant composed of polymer without naltrexone, surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.
Naltrexone Plasma Levels (Peak)	5.03 ng/mL Standard Deviation 1.60	8.55 ng/mL Standard Deviation 2.66	NA ng/mL Standard Deviation NA Data were below the lower limit of quantification

PRIMARY outcome

Time to maximum observed plasma concentration (Tmax) of naltrexone following implant placement.

Outcome measures

Outcome measures
Measure	BIOPIN 6 - 4.8 g Implant n=6 Participants Single BIOPIN 6 implant containing 4.8 g naltrexone surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.	BIOPIN 6 - 9.6 g Implant n=6 Participants Two BIOPIN 6 implants containing a total of 9.6 g naltrexone surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.	Placebo Implant n=4 Participants Placebo implant composed of polymer without naltrexone, surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.
Time to Peak Plasma Concentration of Naltrexone (Tmax)	840 Hours Full Range 408 • Interval 336.0 to 1344.0	708 Hours Full Range 360 • Interval 336.0 to 1008.0	NA Hours Full Range 0 Not applicable (NA) because plasma naltrexone concentrations in the placebo group were below the lower limit of plasma naltrexone concentrations in the placebo group were below the lower limit of quantification (LLOQ) at all assessed time points; therefore, no measurable peak concentration was observed and Tmax could not be determined.

PRIMARY outcome

Area under the plasma concentration-time curve (AUC) of 6-β-naltrexol from implant placement through Day 98. Plasma concentrations below the lower limit of quantification (LLOQ) were represented as 0 in the reported results; therefore, 0 values do not represent placeholder entries.

Outcome measures

Outcome measures
Measure	BIOPIN 6 - 4.8 g Implant n=6 Participants Single BIOPIN 6 implant containing 4.8 g naltrexone surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.	BIOPIN 6 - 9.6 g Implant n=6 Participants Two BIOPIN 6 implants containing a total of 9.6 g naltrexone surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.	Placebo Implant n=4 Participants Placebo implant composed of polymer without naltrexone, surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.
6-β-naltrexol Plasma Concentration Area Under the Curve (AUC₀-98 Days)	33,389 ng*h/mL Standard Deviation 11,564	63,874 ng*h/mL Standard Deviation 18,039	NA ng*h/mL Standard Deviation NA Data were below the lower limit of quantification

PRIMARY outcome

Outcome measures

Outcome measures
Measure	BIOPIN 6 - 4.8 g Implant n=6 Participants Single BIOPIN 6 implant containing 4.8 g naltrexone surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.	BIOPIN 6 - 9.6 g Implant n=6 Participants Two BIOPIN 6 implants containing a total of 9.6 g naltrexone surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.	Placebo Implant n=4 Participants Placebo implant composed of polymer without naltrexone, surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.
6-β-naltrexol Peak Plasma Concentration (Cmax)	12.53 ng/mL Standard Deviation 4.13	22.26 ng/mL Standard Deviation 6.68	NA ng/mL Standard Deviation NA Data were below the lower limit of quantification

PRIMARY outcome

Timeframe: Day 0 to Day 98

Time to maximum observed plasma concentration (Tmax) of 6-β-naltrexol following implant placement.

Outcome measures

Outcome measures
Measure	BIOPIN 6 - 4.8 g Implant n=6 Participants Single BIOPIN 6 implant containing 4.8 g naltrexone surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.	BIOPIN 6 - 9.6 g Implant n=6 Participants Two BIOPIN 6 implants containing a total of 9.6 g naltrexone surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.	Placebo Implant n=4 Participants Placebo implant composed of polymer without naltrexone, surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.
Time to Peak Plasma Concentration of 6-β-naltrexol (Tmax)	1008 Hours Interval 504.0 to 1512.0	840 Hours Interval 336.0 to 1344.0	NA Hours plasma naltrexone concentrations in the placebo group were below the lower limit of quantification (LLOQ) at all assessed time points; therefore, no measurable peak concentration was observed and Tmax could not be determined.

Adverse Events

BIOPIN 6 - 4.8 g Implant

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

BIOPIN 6 - 9.6 g Implant

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo Implant

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Steven M. Cohen, MD, FACS

Akyso Therapeutics, LLC

Phone: 7272700659

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	BIOPIN 6 - 4.8 g Implant n=6 participants at risk Single BIOPIN 6 implant containing 4.8 g naltrexone surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.	BIOPIN 6 - 9.6 g Implant n=6 participants at risk Two BIOPIN 6 implants containing a total of 9.6 g naltrexone surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.	Placebo Implant n=4 participants at risk Placebo implant composed of polymer without naltrexone, surgically implanted subcutaneously in the upper abdomen and maintained for 12 weeks prior to removal.
Gastrointestinal disorders Abdominal pain upper	16.7% 1/6 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/4 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
Nervous system disorders Dizziness	50.0% 3/6 • Number of events 3 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/4 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
Nervous system disorders Headache	50.0% 3/6 • Number of events 3 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	33.3% 2/6 • Number of events 2 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	25.0% 1/4 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
General disorders Fatigue	33.3% 2/6 • Number of events 2 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/4 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
General disorders Implant site edema	16.7% 1/6 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	33.3% 2/6 • Number of events 2 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/4 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
General disorders Influenza like illness	16.7% 1/6 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/4 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	16.7% 1/6 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/4 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
Musculoskeletal and connective tissue disorders Myalgia	16.7% 1/6 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/4 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
Skin and subcutaneous tissue disorders Acne	16.7% 1/6 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/4 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
Skin and subcutaneous tissue disorders Hyperhidrosis	16.7% 1/6 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/4 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
Immune system disorders Seasonal allergy	16.7% 1/6 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/4 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
Injury, poisoning and procedural complications Seroma	16.7% 1/6 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	16.7% 1/6 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/4 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
Psychiatric disorders Poor quality sleep	16.7% 1/6 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/4 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
Renal and urinary disorders Pollakiuria	16.7% 1/6 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/4 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
Reproductive system and breast disorders Breast tenderness	16.7% 1/6 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/4 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
Gastrointestinal disorders Nausea	50.0% 3/6 • Number of events 3 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	16.7% 1/6 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/4 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
Gastrointestinal disorders Diarrhoea	33.3% 2/6 • Number of events 2 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/4 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
Gastrointestinal disorders Vomiting	33.3% 2/6 • Number of events 2 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/4 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/4 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	16.7% 1/6 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/4 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	16.7% 1/6 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/4 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
Investigations Aspartate aminotransferase increased	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	16.7% 1/6 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/4 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	16.7% 1/6 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/4 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
Gastrointestinal disorders Abdominal distension	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	25.0% 1/4 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
Infections and infestations Otitis media	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	25.0% 1/4 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
Injury, poisoning and procedural complications Contusion	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	25.0% 1/4 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	25.0% 1/4 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	0.00% 0/6 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.	25.0% 1/4 • Number of events 1 • Day 0 to Day 98 Adverse events were collected from implantation through explantation and the post-explant recovery follow-up period. Events were graded using CTCAE v5.0 and coded using MedDRA terminology. Treatment-emergent adverse events include all events occurring after implantation regardless of attribution.